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17 Study Matches
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
Toll Free Number - Trialsites@msd.com
NCT06136650
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Have histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while receiving androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months before screening
* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease shown by computed tomography (CT)/magnetic resonance imaging (MRI)
* Has disease that progressed during or after treatment with one next-generation hormonal agent (NHA) for hormone sensitive prostate cancer (HSPC) (metastatic hormone-sensitive prostate cancer \[mHSPC\] or non-metastatic hormone-sensitive prostate cancer \[nmHSPC\]), or castration-resistant prostate cancer (CRPC) (metastatic castration-resistant prostate cancer \[mCRPC\] or non-metastatic castration-resistant prostate cancer \[nmCRPC\]), for at least 8 weeks of NHA treatment (at least 14 weeks of NHA treatment for participants with bone progression). Note: Participants may have received abiraterone acetate and docetaxel or darolutamide and docetaxel for HSPC. However, participants must have received no more than 6 cycles of docetaxel and had no radiographic disease progression while receiving docetaxel
* Has had prior treatment with poly (ADP-ribose) polymerase inhibitor (PARPi) or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has ongoing androgen deprivation therapy (ADT) with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has an eastern clinical oncology group (ECOG) performance status of 0 or 1 assessed within 10 days before randomization
* Has adequate organ function
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
* Participants who have adverse event (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or ≤Grade 2 osteopenia/osteoporosis are eligible
* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has presence of gastrointestinal condition
* Is unable to swallow capsules/tablets
* Has history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has any of the following at screening visit: Hypotension: systolic blood pressure (BP) \<110 mmHg, or uncontrolled hypertension: systolic BP ≥160mmHg or diastolic blood BP ≥90 mmHg, in 2 out of the 3 recordings with optimized antihypertensive therapy
* Has a history of active or unstable cardio/cerebrovascular disease, including thromboembolic events
* History or family history of long QTc syndrome
* Has a history of seizure(s) within 6 months before providing documented informed consent (IC) or has any condition that may predispose to seizure within 12 months prior to the date of enrollment
* Has a history of clinically significant ventricular arrhythmias or Mobitz II second degree or third-degree heart block without a permanent pacemaker in place
* Has received a taxane-based chemotherapy for metastatic castration-resistant prostate cancer (mCRPC)
* Has not adequately recovered from major surgery or have ongoing surgical complications
* Is currently being treated with Cytochrome P450 (CYP450)-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy, as judged by the investigator, within 6 months before the start of the study intervention
* Receives prior radiotherapy within 2 weeks before the first dose of study intervention, or radiation-related toxicities, requiring corticosteroids
* Receives prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Has systemic use of strong Cytochrome P450 3A4 (CYP3A4) inducers and P-glycoprotein (P-gp) inhibitors within 2 weeks before the first dose of study intervention
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
* Has known hypersensitivity to the components or excipients in abiraterone acetate, prednisone or prednisolone, enzalutamide, fludrocortisone, dexamethasone, or opevesostat
* Has a "superscan" bone scan defined as an intense symmetric activity in the bones and diminished renal parenchymal activity on baseline bone scan such that the presence of additional metastases in the future could not be evaluated
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable and have not required steroid treatment for at least 14 days prior to the first dose of study intervention
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is allowed
* Active infection requiring systemic therapy
* Has concurrent active Hepatitis B virus and Hepatitis C virus infection DRUG: Opevesostat, DRUG: Dexamethasone, DRUG: Fludrocortisone acetate, DRUG: Hydrocortisone, DRUG: Abiraterone acetate, DRUG: Prednisone acetate, DRUG: Enzalutamide
Metastatic Castration-resistant Prostate Cancer (mCRPC), Prostatic Neoplasms
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Study Locations
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| Location | Contacts |
|---|---|
| ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Site 0552) Chaïdári, Attica | |
| Ad-Vance Medical Research-Research ( Site 1177) Ponce, | |
| Addenbrooke's Hospital ( Site 1426) Cambridge, Cambridgeshire | |
| Advance Urology and Laparoscopic Center ( Site 1178) Ponce, | |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1301) Uppsala, Uppsala County | |
| Akita University Hospital ( Site 0728) Akita, | |
| Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 0551) Athens, Attica | |
| Aliada-Oncologìa ( Site 1055) Lima, | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1377) Ankara, | |
| Associated Medical Professionals - Urology ( Site 0081) Syracuse, New York | |
| Auckland City Hospital ( Site 1033) Auckland, | |
| Avera Cancer Institute - Aberdeen (Site 0123) Aberdeen, South Dakota | Ryan Vaca - (ryan.vaca@avera.org) |
| Avera Cancer Institute - Marshall (Site 0122) Marshall, Minnesota | Ryan Vaca - (ryan.vaca@avera.org) |
| Avera Cancer Institute - Mitchell (Site 0121) Mitchell, South Dakota | Ryan Vaca - (ryan.vaca@avera.org) |
| Avera Cancer Institute - Pierre ( Site 0118) Pierre, South Dakota | |
| Avera Cancer Institute - Yankton ( Site 0117) Yankton, South Dakota | |
| Avera Cancer Institute- Research ( Site 0094) Sioux Falls, South Dakota | |
| Azienda Ospedaliera Santa Maria Terni ( Site 1458) Terni, | |
| Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 1456) Foggia, | |
| BC Cancer Abbotsford-Clinical Trials Unit (Site 0287) Abbotsford British Columbia, British Columbia | Jenny Ko - (jenny.ko@bccancer.bc.ca) |
| Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1379) Adana, | |
| Beijing Cancer Hospital ( Site 1623) Beijing, Beijing Municipality | |
| Beijing Cancer hospital-Urinary Surgery ( Site 1620) Beijing, Beijing Municipality | |
| Bell Land General Hospital ( Site 0740) Sakai, Osaka | |
| Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia | |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás C ( Site 0630) Miskolc, Borsod-Abauj Zemplen county | |
| Bradfordhill-Clinical Area ( Site 0301) Santiago, Region M. de Santiago | |
| CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE-Clinical Trials Unit ( Site 1230) Port Elizabeth, Eastern Cape | |
| CELAN,S.A ( Site 0579) Guatemala City, | |
| CENTRE LEON BERARD ( Site 0459) Lyon Cedex08, Auvergne-Rhône-Alpes | |
| CHU-BREST Cavale Blanche ( Site 0456) Brest, Finistere | |
| CIDO SpA-Oncology ( Site 0302) Temuco, Araucania | |
| CIMCA-Hemato-Oncology ( Site 0380) San José, Provincia de San José | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 0928) Guadalajara, Jalisco | |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0256) Fortaleza, Ceará | |
| Cancer and Hematology Centers of Western Michigan ( Site 0005) Grand Rapids, Michigan | |
| Cape Town Oncology Trials ( Site 1233) Cape Town, Western Cape | |
| Cardiomed SRL Cluj-Napoca ( Site 1503) Cluj-Napoca, Cluj | |
| Caritas-Krankenhaus St. Josef-Klinik fuer Urologie ( Site 0523) Regensburg, Bavaria | |
| Central Ohio Urology Group - Gahanna ( Site 0098) Gahanna, Ohio | |
| Centre Bourgogne ( Site 0464) Lille, Hauts-de-France | |
| Centre Hospitalier de l'Université de Montréal ( Site 0276) Montreal, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0454) Clermont-Ferrand, Puy-de-Dome | |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0277) Québec, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 0934) Oaxaca City, Oaxaca | |
| Centrul de Oncologie "Sfântul Nectarie" ( Site 1501) Craiova, Dolj | |
| Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1334) Taoyuan, | |
| Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 1331) Kaohsiung City, | |
| Charing Cross Hospital-Oncology Research ( Site 1434) London, Hammersmith and Fulham | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0504) Berlin, | |
| Chesapeake Urology ( Site 0009) Towson, Maryland | |
| Chi Mei Medical Center ( Site 1336) Tainan, Tainan | |
| China Medical University Hospital-Department of Urology ( Site 1335) Taichung, | |
| Chongqing University Cancer Hospital ( Site 1603) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1355) Bangkok, Bangkok | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0326) Bogotá, Bogota D.C. | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0306) Talca, Maule Region | |
| Clínica Imbanaco S.A.S ( Site 0334) Cali, Valle del Cauca Department | |
| Clínica de Neoplasias Litoral ( Site 0269) Itajaí, Santa Catarina | |
| Colorado Clinical Research ( Site 0067) Lakewood, Colorado | |
| Complexo Hospitalario Universitario A Coruna ( Site 1288) A Coruña, La Coruna | |
| Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada | |
| Cross Cancer Institute (Site 0281) Edmonton, Alberta | Michael Kolinsky - (michael.kolinsky@ahs.ca) |
| Curo Oncology. ( Site 1237) Pretoria, Gauteng | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0632) Debrecen, | |
| Delta Health Care SRL (Site 1507) Bucharest, | Andrea Craciunescu - (deea06@yahoo.com) |
| Dunedin Hospital ( Site 1032) Dunedin, Otago | |
| East-Tallinn Central Hospital ( Site 1528) Tallinn, Harju | |
| Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0075) Naperville, Illinois | |
| Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0074) Elmhurst, Illinois | |
| Ege Universitesi Hastanesi-Medical Oncology ( Site 1380) Izmir, | |
| Emad Ibrahim,MD,INC. ( Site 0012) Redlands, California | |
| Emek Medical Center ( Site 0680) Afula, | |
| Eukarya Pharmasite S.C. ( Site 0939) Monterrey, Nuevo León | |
| FALP ( Site 0303) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 1351) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 1356) Bangkok, Bangkok | |
| Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0404) Brno, South Moravian | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0405) Olomouc, | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0401) Prague, Praha 5 | |
| Filios Alta Medicina ( Site 0931) Monterrey, Nuevo León | |
| First Medical Center of Chinese PLA General Hospital ( Site 1601) Beijing, Beijing Municipality | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1452) Milan, Lombardy | |
| Fox Chase Cancer Center ( Site 0076) Philadelphia, Pennsylvania | |
| Fukushima Medical University Hospital ( Site 0758) Fukushima, | |
| Fundación Cardiovascular de Colombia ( Site 0328) Piedecuesta, Santander Department | |
| Fundación Valle del Lili ( Site 0330) Cali, Valle del Cauca Department | |
| Genesis Healthcare System ( Site 0102) Zanesville, Ohio | |
| GenesisCare - Oxford ( Site 1442) Oxford, Oxfordshire | |
| GenesisCare - Windsor ( Site 1443) Windsor, Windsor And Maidenhead | |
| Gifu University Hospital ( Site 0736) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland | |
| Groupe Hospitalier Paris Saint Joseph ( Site 0465) Paris, | |
| Gustave Roussy ( Site 0452) Villejuif, Val-de-Marne | |
| Guy's & St Thomas' NHS Foundation Trust-Oncology & Haematology Clinical Trials ( Site 1435) London, London, City of | |
| HOSPITAL CLÍNIC DE BARCELONA-ICHMO- Clinic Institut of Haematological and Oncological diseases ( Site 1284) Barcelona, Catalonia | |
| HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1283) Pozuelo de Alarcón, Madrid | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1376) Ankara, | |
| Hadassah Medical Center ( Site 0683) Jerusalem, | |
| Health Pharma Professional Research S.A. de C.V: ( Site 0929) Mexico City, Mexico City | |
| HealthPartners Cancer Research Center-HealthPartners Cancer Center at Regions Hospital ( Site 0092) Saint Paul, Minnesota | |
| HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0072) Saint Louis Park, Minnesota | |
| Henry Ford Hospital ( Site 0015) Detroit, Michigan | |
| Higiea Oncologia ( Site 0938) Mexico City, Mexico City | |
| Hiroshima University Hospital ( Site 0743) Hiroshima, | |
| Hokkaido University Hospital ( Site 0756) Sapporo, Hokkaido | |
| Hong Kong Integrated Oncology Centre ( Site 0603) Central, | |
| Hospital CUF - Tejo ( Site 1157) Lisbon, | |
| Hospital Insular de Gran Canaria-Oncology ( Site 1280) Las Palmas de Gran Canaria, Las Palmas | |
| Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 0903) Kuala Lumpur, | |
| Hospital Mario Penna ( Site 0264) Belo Horizonte, Minas Gerais | |
| Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0379) Santa Ana, Provincia de San José | |
| Hospital Paulistano ( Site 0259) São Paulo, | |
| Hospital Quirón Málaga ( Site 1286) Málaga, | |
| Hospital Santa Rita de Cassia ( Site 0271) Vitória, Espírito Santo | |
| Hospital Sultan Ismail ( Site 0905) Johor Bahru, Johor | |
| Hospital São Domingos ( Site 0258) São Luís, Maranhão | |
| Hospital São Lucas da PUCRS ( Site 0270) Porto Alegre, Rio Grande do Sul | |
| Hospital Universitari Parc Tauli-oncologia ( Site 1282) Sabadell, Barcelona | |
| Hospital Universitario "Dr. Jose Eleuterio Gonzalez"-Servicio de Oncología ( Site 0932) Monterrey, Nuevo León | |
| Hospital Universitario de Burgos-Oncología ( Site 1281) Burgos, | |
| Hospital Universitário Evangélico Mackenzie ( Site 0252) Curitiba, Paraná | |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0251) Bragança Paulista, São Paulo | |
| Hospital de Base de São José do Rio Preto ( Site 0275) São José do Rio Preto, São Paulo | |
| Hospital de Cascais Doutor José de Almeida ( Site 1158) Alcabideche, Lisbon District | |
| Hospital of Lithuanian University of Health Sciences Kauno klinikos ( Site 1576) Kaunas, Kaunas County | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 0746) Kitakyushu, Fukuoka | |
| Huadong Hospital Affiliated to Fudan University-Urology ( Site 1613) Shanghai, Shanghai Municipality | |
| Hubei Cancer Hospital-Urinary surgery ( Site 1631) Wuhan, Hubei | |
| Hunan Cancer Hospital ( Site 1630) Changsha, Hunan | |
| Hôpital Foch ( Site 0455) Suresnes, Hauts-de-Seine | |
| ICTRIALS Pesquisa e Desenvolvimento ( Site 0274) Curitiba, Paraná | |
| IMAT S.A.S ( Site 0329) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1054) Lima, | |
| INTEGRA Cancer Institute-Oncology ( Site 0578) Guatemala City, | |
| IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1052) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 1454) Meldola, Emilia-Romagna | |
| Illinois Cancer Care ( Site 0104) Peoria, Illinois | |
| Inova Schar Cancer Institute ( Site 0017) Fairfax, Virginia | |
| Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest ( Site 0461) Bordeaux, Aquitaine | |
| Institut Català d'Oncologia (ICO) - Girona ( Site 1285) Girona, Gerona | |
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0451) Strasbourg, Alsace | |
| Instituto do Câncer Brasil - Unidade Taubaté ( Site 0263) Taubaté, São Paulo | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1383) Istanbul, | |
| Kagawa University Hospital ( Site 0744) Kita, Kagawa-ken | |
| Kagoshima University Hospital ( Site 0754) Kagoshima, | |
| Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California | |
| Kaiser Permanente-Kaiser Permanente, Vallejo Medical Center, Adult Oncology ( Site 0101) Vallejo, California | |
| Kanazawa Medical University Hospital ( Site 0734) Mukai-awagasaki, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0739) Hirakata, Osaka | |
| Kaohsiung Veterans General Hospital ( Site 1337) Kaohsiung City, | |
| Karolinska Universitetssjukhuset Solna ( Site 1302) Stockholm, Stockholm County | |
| Kobe University Hospital ( Site 0741) Kobe, Hyōgo | |
| Koc Universitesi Hastanesi ( Site 1384) Istanbul, | |
| Krajská nemocnice Liberec-Department of Urology ( Site 0407) Liberec, Liberec Region | |
| Kyungpook National University Chilgok Hospital-Urology ( Site 1252) Buk-gu, Kyongsangbuk-do | |
| Kyushu University Hospital ( Site 0745) Fukuoka, | |
| LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 1236) Pretoria, Gauteng | |
| Liepaja Regional Hospital ( Site 1553) Liepāja, | |
| Los Cobos Medical Center ( Site 0336) Bogotá, Bogota D.C. | |
| MEDI-K ( Site 0576) Guatemala City, | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0214) Macquarie University, New South Wales | |
| Maharaj Nakorn Chiang Mai Hospital ( Site 1353) Muang, Chiang Mai | |
| Marien-Krankenhaus ( Site 0515) Bergisch Gladbach, North Rhine-Westphalia | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0403) Brno, Brno-mesto | |
| MedStar Washington Hospital Center ( Site 0103) Washington D.C., District of Columbia | |
| Meir Medical Center. ( Site 0682) Kfar Saba, | |
| Memorial Hospital West-Memorial Cancer Institute ( Site 0109) Pembroke Pines, Florida | |
| MidLantic urology ( Site 0022) Bala-Cynwyd, Pennsylvania | |
| Mie University Hospital ( Site 0737) Tsu, Mie-ken | |
| Miyazaki Prefectural Miyazaki Hospital ( Site 0752) Miyazaki, | |
| Monash Health ( Site 0219) Clayton, Victoria | |
| Mount Sinai Cancer Center ( Site 0107) Miami Beach, Florida | |
| Mount Vernon Cancer Centre ( Site 1440) Northwood, England | |
| Nagano Municipal Hospital ( Site 0757) Nagano, | |
| Nanbu Tokushukai Hospital ( Site 0755) Shimajiri, Okinawa | |
| Nanchong Central Hospital-urology ( Site 1647) Nanchong, Sichuan | |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1615) Nanjing, Jiangsu | |
| Nantong Tumor Hospital-Urology ( Site 1609) Nantong, Jiangsu | |
| Nara Medical University Hospital ( Site 0742) Kashihara, Nara | |
| National Cancer Center-Center for Urologic Cancer ( Site 1254) Goyang-si, Kyonggi-do | |
| National Cancer Centre Singapore ( Site 1202) Singapore, Central Singapore | |
| National Cancer Institute ( Site 0904) Putrajaya, Putrajaya | |
| National Cancer Institute ( Site 1577) Vilnius, Vilniaus Miestas | |
| National Hospital Organization Kumamoto Medical Center ( Site 0749) Kumamoto, | |
| National Hospital Organization Nagasaki Medical Center ( Site 0748) Ōmura, Nagasaki | |
| National Hospital Organization Oita Medical Center ( Site 0750) Ōita, | |
| National University Hospital ( Site 1201) Singapore, Central Singapore | |
| Nihon University Itabashi Hospital ( Site 0732) Itabashiku, Tokyo | |
| Ningbo First Hospital-Urology ( Site 1608) Ningbo, Zhejiang | |
| Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0636) Salgótarján, Nógrád megye | |
| North Estonia Medical Centre Foundation ( Site 1526) Tallinn, Harju | |
| Northside Hospital-Northside Hospital Oncology Network ( Site 0100) Atlanta, Georgia | |
| Northwest Cancer Specialists (Compass Oncology) ( Site 8008) Vancouver, Washington | |
| ONCOCENTRO APYS-ACEREY ( Site 0305) Viña del Mar, Valparaiso | |
| Obras Sociais Irma Dulce ( Site 0255) Salvador, Estado de Bahia | |
| Onco Tech, S.A. ( Site 0376) San José, | |
| Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 0026) Omaha, Nebraska | |
| Oncosalud-Clinical Research ( Site 1057) Lima, | |
| OptumCare Cancer Care-Research Department ( Site 0078) Las Vegas, Nevada | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0631) Budapest, Pest County | |
| Ospedale Cannizzaro ( Site 1455) Catania, | |
| Ospedale San Raffaele-Oncologia Medica ( Site 1451) Milan, | |
| Pan American Center for Oncology Trials - Ciudadela ( Site 1176) San Juan, | |
| Pauls Stradins Clinical Univeristy Hospital-Urological department ( Site 1551) Riga, | |
| Peking University First Hospital-Urology ( Site 1602) Beijing, Beijing Municipality | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0210) Melbourne, Victoria | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0304) Santiago, Region M. de Santiago | |
| Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 0577) Guatemala City, | |
| Privatna Urologicka Ambulancia ( Site 1478) Trenčín, Trenčín Region | |
| Pusan National University Yangsan Hospital ( Site 1256) Pusan, Kyongsangnam-do | |
| Pärnu Haigla (Site 1550) Pärnu, Pärnumaa | Helis Pokker - (helis.pokker@regionaalhaigla.ee) |
| Queen Mary Hospital ( Site 0602) Hong Kong, | |
| Quemex Medical and Research ( Site 0937) Tlalpan, Mexico City | |
| Rabin Medical Center ( Site 0678) Petah Tikva, | |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina | |
| Rambam Health Care Campus-Oncology Division ( Site 0676) Haifa, | |
| Ramsay Santé - Clinical La Croix Du Sud ( Site 0460) Quint-Fonsegrives, Haute-Garonne | |
| Renji Hosp Shanghai Jiaotong U School of Med ( Site 1624) Shanghai, Shanghai Municipality | |
| Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0211) Brisbane, Queensland | |
| Royal Derby Hospital ( Site 1431) Derby, Derbyshire | |
| Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey | |
| SC Radiotherapy Center Cluj SRL ( Site 1502) Florești, Cluj | |
| Saga-Ken Medical Centre Koseikan ( Site 0747) Saga, Saga-ken | |
| Sainte Catherine Institut du Cancer Avignon Provence ( Site 0458) Avignon, Vaucluse | |
| Samsun Medical Park Hastanesi-medical oncology ( Site 1382) Samsun, | |
| San Francisco VA Health Care System ( Site 0093) San Francisco, California | |
| Sanatorio Nuestra Senora del Pilar ( Site 0580) Guatemala City, | |
| Sapporo Medical University Hospital ( Site 0726) Sapporo, Hokkaido | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 0901) Kuching, Sarawak | |
| Seoul National University Bundang Hospital-Urology ( Site 1253) Seongnam, Kyonggi-do | |
| Seoul National University Hospital-Urology ( Site 1251) Seoul, | |
| Shaare Zedek Medical Center ( Site 0679) Jerusalem, | |
| Sheba Medical Center ( Site 0677) Ramat Gan, | |
| Singapore General Hospital ( Site 1204) Singapore, Central Singapore | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0327) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1352) Hat Yai, Changwat Songkhla | |
| Sourasky Medical Center ( Site 0681) Tel Aviv, | |
| Southwest Hospital of Third Military Medical University ( Site 1645) Chongqing, Chongqing Municipality | |
| Spitalul Clinic ''Prof Dr. Theodor Burghele" (Site 1505) Bucharest, | Viorel Jinga - (vioreljinga@gmail.com) |
| Spitalul Universitar de Urgență Elias ( Site 1504) Bucharest, Bucharest | |
| Spokane Urology ( Site 0035) Spokane, Washington | |
| St. George's Hospital-Oncology ( Site 1441) London, London, City of | |
| St. Vincent Frontier Cancer Center-Research ( Site 0037) Billings, Montana | |
| St. Vincent's University Hospital ( Site 0652) Dublin, Dublin | |
| Stanford Cancer Center ( Site 0036) Palo Alto, California | |
| Studienpraxis Urologie ( Site 0529) Nürtingen, Baden-Wurttemberg | |
| Sun Yat-sen University Cancer Center-Urology Surgery ( Site 1638) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0285) Toronto, Ontario | |
| T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training ( Site 1381) Istanbul, | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1378) Istanbul, | |
| Taichung Veterans General Hospital ( Site 1338) Taichung, | |
| Taipei Veterans General Hospital ( Site 1332) Taipei, | |
| Tallaght University Hospital ( Site 0651) Dublin, | |
| Tan Tock Seng Hospital-Medical Oncology ( Site 1203) Singapore, Central Singapore | |
| Tartu University Hospital-Radiotherapy and oncology ( Site 1527) Tartu, Tartu | |
| Texas Oncology - Central/South Texas ( Site 8003) Austin, Texas | |
| Texas Oncology - DFW ( Site 8001) Dallas, Texas | |
| Texas Oncology - Gulf Coast ( Site 8002) The Woodlands, Texas | |
| The Beatson West of Scotland Cancer Centre ( Site 1428) Glasgow, Glasgow City | |
| The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1255) Seoul, | |
| The Central Hospital of Wuhan ( Site 1635) Wuhan, Hubei | |
| The Christie NHS Foundation Trust ( Site 1436) Manchester, | |
| The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 1639) Fuzhou, Fujian | |
| The First Affiliated Hospital of Wenzhou Medical University ( Site 1604) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology department ( Site 1618) Xi'an, Shaanxi | |
| The First Hospital of Jiaxing-urology ( Site 1605) Jiaxing, Zhejiang | |
| The Jikei University Hospital ( Site 0731) Minato, Tokyo | |
| The Ottawa Hospital - General Campus ( Site 0286) Ottawa, Ontario | |
| The Royal Cornwall Hospital ( Site 1430) Truro, England | |
| The Second Affiliated Hospital of Xi'an Jiaotong University-Oncology Department ( Site 1619) Xi'an, Shaanxi | |
| The Second Hospital Of Anhui Medical University ( Site 1633) Hefei, Anhui | |
| The Second Hospital of Tianjin Medical University ( Site 1616) Tianjin, Tianjin Municipality | |
| The University of Arizona Cancer Center - North Campus ( Site 0073) Tucson, Arizona | |
| The University of Osaka Hospital ( Site 0738) Suita, Osaka | |
| The West Clinic, PLLC dba West Cancer Center ( Site 0063) Germantown, Tennessee | |
| The first affiliated hospital of Guangzhou medical university ( Site 1637) Guangzhou, Guangdong | |
| Toho University Sakura Medical Center ( Site 0730) Sakura, Chiba | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 1632) Wuhan, Hubei | |
| Torbay Hospital ( Site 1429) Torquay, Devon | |
| Trillium Health Partners - Credit Valley Hospital ( Site 0289) Mississauga, Ontario | |
| UCHealth Highlands Ranch Hospital ( Site 0111) Highlands Ranch, Colorado | |
| UCLA Hematology/Oncology - Santa Monica ( Site 0044) Los Angeles, California | |
| UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 0553) Pátrai, Achaia | |
| UROEXAM ( Site 1479) Nitra, Nitra Region | |
| Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1156) Vila Nova de Gaia, Porto District | |
| Unidade Local de Saude de Braga - Hospital de Braga ( Site 1151) Braga, | |
| Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1153) Lisbon, | |
| Unidade Local de Saude de Santo António - Hospital Santo António ( Site 1152) Porto, | |
| Universidade Federal do Triangulo Mineiro - Hospital de Clinicas ( Site 0262) Uberaba, Minas Gerais | |
| Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 0528) Dresden, Saxony | |
| Universitaetsklinikum Freiburg-Klinik für Urologie ( Site 0506) Freiburg im Breisgau, Baden-Wurttemberg | |
| Universitaetsklinikum Heidelberg ( Site 0531) Heidelberg, Baden-Wurttemberg | |
| Universitaetsklinikum Koeln ( Site 0518) Cologne, North Rhine-Westphalia | |
| University College London Hospital ( Site 1437) London, London, City of | |
| University Hospitals Cleveland Medical Center ( Site 0043) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 0902) Lembah Pantai, Kuala Lumpur | |
| University of California Davis (UC Davis) Comprehensive Cancer Center ( Site 0114) Sacramento, California | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) Orange, California | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center (0120) Orange, California | Arash Rezazadeh Kalebasty - (arez@hs.uci.edu) |
| University of Colorado Anschutz Medical Campus ( Site 0046) Aurora, Colorado | |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) Lone Tree, Colorado | |
| University of Fukui Hospital ( Site 0735) Eiheiji-cho,Yoshida-gun, Fukui | |
| University of Kentucky Chandler Medical Center ( Site 0048) Lexington, Kentucky | |
| University of Miyazaki Hospital ( Site 0751) Miyazaki, | |
| University of Virginia Health System ( Site 0054) Charlottesville, Virginia | |
| Universitätsklinikum Marburg-Comprehensive Cancer Center ( Site 0510) Marburg, Hesse | |
| Universitätsmedizin Göttingen - Georg-August-Universität-Klinik für Urologie ( Site 0527) Göttingen, Lower Saxony | |
| Urologicum Duisburg (Site 00538) Duisburg, North Rhine-Westphalia | Eva Hellmis - (hellmis@urologicum-duisburg.de) |
| Urology of Indiana - Carmel ( Site 0055) Carmel, Indiana | |
| VCU Health Adult Outpatient Pavillion ( Site 0061) Richmond, Virginia | |
| Virginia Cancer Specialists (VCS) ( Site 8004) Fairfax, Virginia | |
| Vivantes Klinikum Am Urban ( Site 0512) Berlin, | |
| Vseobecna fakultni nemocnice v Praze ( Site 0406) Prague, | |
| West China Hospital, Sichuan University-Urology Surgery ( Site 1642) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0212) Westmead, New South Wales | |
| Wilgers Oncology Centre ( Site 1232) Pretoria, Gauteng | |
| Wits Clinical Research ( Site 1234) Johannesburg, Gauteng | |
| Wuxi People's Hospital ( Site 1612) Wuxi, Jiangsu | |
| Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 1644) Ürümqi, Xinjiang | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) New Haven, Connecticut | |
| Yantai Yuhuangding Hospital ( Site 1622) Yantai, Shandong | |
| Yokohama City University Medical Center ( Site 0733) Yokohama, Kanagawa | |
| Yunnan Province Cancer Hospital ( Site 1643) Kunming, Yunnan | |
| Zhejiang Provincial People's Hospital-Urology ( Site 1641) Hangzhou, Zhejiang | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0521) Munich, Bavaria |
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
Dana Sparks, MAT - dsparks@swog.org
Paul, Asit, K.
NCT03678025
HM20016134
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Inclusion Criteria:
* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma\* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (\*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride \[NaF\], prostate-specific membrane antigen \[PSMA\], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid \[FACBC\], carbon \[C\]11) but not conventional imaging (technetium \[Tc\]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
* STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
* STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
* STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
* STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
* STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
* STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.
* STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
* STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
* STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
* STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
* STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
* STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
* STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
* STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
* STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =\< grade 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) prior to randomization.
* STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=\< 4 sites). All treatment must be completed prior to randomization.
* STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
* STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone \< 50 ng/dL within 28 days prior to randomization.
* STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization. DRUG: Abiraterone, DRUG: Bicalutamide, DRUG: Degarelix, DRUG: Docetaxel, DRUG: Flutamide, DRUG: Goserelin Acetate, DRUG: Histrelin Acetate, DRUG: Leuprolide Acetate, DRUG: Nilutamide, PROCEDURE: Orchiectomy, DRUG: Prednisone, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, PROCEDURE: Radical Prostatectomy, DRUG: Triptorelin
Castration Levels of Testosterone, Stage IV Prostate Cancer AJCC v8, Metastatic Prostatic Adenocarcinoma, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8
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Show 338 locations
Study Locations
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| Location | Contacts |
|---|---|
| 21st Century Oncology-Pontiac Pontiac, Michigan | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Albany Medical Center Albany, New York | |
| American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah | |
| Ascension Saint Mary's Hospital Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Ascension Saint Michael's Hospital Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atlanta VA Medical Center Decatur, Georgia | |
| Atrium Health Cabarrus/LCI-Concord Concord, North Carolina | |
| Atrium Health Pineville/LCI-Pineville Charlotte, North Carolina | |
| Atrium Health Stanly/LCI-Albemarle Albemarle, North Carolina | |
| Atrium Health Union/LCI-Union Monroe, North Carolina | |
| Atrium Health University City/LCI-University Charlotte, North Carolina | |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| Augusta University Medical Center Augusta, Georgia | Site Public Contact - (ga_cares@augusta.edu) |
| Banner MD Anderson Cancer Center Gilbert, Arizona | |
| Baptist MD Anderson Cancer Center Jacksonville, Florida | |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas | Site Public Contact - (burton@bcm.edu) |
| Ben Taub General Hospital Houston, Texas | |
| Benefis Healthcare- Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bozeman Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (CancerInstitute@DignityHealth.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carolina Regional Cancer Center Myrtle Beach, South Carolina | |
| CarolinaEast Medical Center New Bern, North Carolina | Site Public Contact - (lharrison@carolinaeasthealth.com) |
| Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (ctsucontact@westat.com) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Site Public Contact - (becomingapatient@coh.org) |
| Cleveland Clinic Mercy Hospital Canton, Ohio | |
| Community Cancer Institute Clovis, California | |
| Comprehensive Cancer Centers of Nevada Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Henderson Henderson, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada - Northwest Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| CoxHealth South Hospital Springfield, Missouri | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delbert Day Cancer Institute at PCRMC Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Desert Regional Medical Center Palm Springs, California | |
| Diagnostic and Treatment Center Weston, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| East Jefferson General Hospital Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Elliot Hospital Manchester, New Hampshire | |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| FHCC Overlake Bellevue, Washington | |
| FHCC South Lake Union Seattle, Washington | |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Fremont - Rideout Cancer Center Marysville, California | |
| Fresno Cancer Center Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California | |
| GenesisCare USA - Clarkston Clarkston, Michigan | Site Public Contact - (Rudi.Ross@usa.genesiscare.com) |
| GenesisCare USA - Farmington Hills Farmington Hills, Michigan | Site Public Contact - (Rudi.Ross@usa.genesiscare.com) |
| GenesisCare USA - Macomb Macomb, Michigan | Site Public Contact - (Rudi.Ross@usa.genesiscare.com) |
| GenesisCare USA - Madison Heights Madison Heights, Michigan | Site Public Contact - (Rudi.Ross@usa.genesiscare.com) |
| GenesisCare USA - Troy Troy, Michigan | Site Public Contact - (Rudi.Ross@usa.genesiscare.com) |
| George E Wahlen Department of Veterans Affairs Medical Center Salt Lake City, Utah | |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Glens Falls Hospital Glens Falls, New York | |
| Grady Health System Atlanta, Georgia | |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Highland Hospital Rochester, New York | |
| Holy Name Hospital Teaneck, New Jersey | |
| Houston Methodist Hospital Houston, Texas | |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana | |
| Instituto Nacional De Cancerologia Mexico City, | |
| Instituto Nacional De Cancerologia de Mexico Mexico City, Tlalpan | |
| Instituto Nacional Del Cancer Santiago, | Site Public Contact - (info@incancer.cl) |
| Intermountain Medical Center Murray, Utah | |
| Iowa Methodist Medical Center Des Moines, Iowa | |
| James J Peters VA Medical Center The Bronx, New York | |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | |
| Kaiser Permanente Cancer Treatment Center South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Oakland-Broadway Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Redwood City Redwood City, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kalispell Regional Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Kantonsspital Aarau Aarau, | |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LDS Hospital Salt Lake City, Utah | |
| LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Lafayette Family Cancer Center-EMMC Brewer, Maine | |
| Lahey Hospital and Medical Center Burlington, Massachusetts | |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Legacy Good Samaritan Hospital and Medical Center Portland, Oregon | |
| Legacy Mount Hood Medical Center Gresham, Oregon | |
| Legacy Salmon Creek Hospital Vancouver, Washington | |
| Levine Cancer Institute-Ballantyne Charlotte, North Carolina | |
| Levine Cancer Institute-Gaston Gastonia, North Carolina | |
| Levine Cancer Institute-Rock Hill Rock Hill, South Carolina | |
| Littleton Adventist Hospital Littleton, Colorado | Site Public Contact - (ResearchTracking@Centura.Org) |
| Logan Regional Hospital Logan, Utah | |
| Los Angeles County-USC Medical Center Los Angeles, California | |
| Loyola University Medical Center Maywood, Illinois | |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Maine Medical Center- Scarborough Campus Scarborough, Maine | Site Public Contact - (wrighd@mmc.org) |
| Maine Medical Center-Bramhall Campus Portland, Maine | |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Coastal Cancer Treatment Center Bath, Maine | Site Public Contact - (ctsucontact@westat.com) |
| MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford, Maine | Site Public Contact - (LLemire@mmc.org) |
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| Michael E DeBakey VA Medical Center Houston, Texas | |
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| Saint George Regional Medical Center St. George, Utah | |
| Saint James Community Hospital and Cancer Treatment Center Butte, Montana | |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Mercy Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
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| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Sandra L Maxwell Cancer Center Cedar City, Utah | |
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Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (INDICATE)
Loney, Shenise - loneys2@vcu.edu
Urdaneta, Alfredo, I
NCT04423211
HM20021980
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Inclusion Criteria:
* STEP 0: REGISTRATION ELIGIBILITY CRITERIA
* Patient must be male and \>= 18 years of age.
* Patient must have had a radical prostatectomy (RP) as definitive therapy for histopathologically-proven prostatic adenocarcinoma
* Patient must have biochemical recurrence (BCR) after RP, defined as follows:
* If time to BCR, defined as time to first detectable PSA ( \> lower limit of normal for assay used) after RP, is \< 12 months, a minimum PSA level of \>= 0.2 ng/mL and a confirmatory reading of \>= 0.2 ng/mL is required, per the American Urological Association (AUA) definition (Note: patients with a persistent PSA reading of at least 0.2 ng/mL are eligible)
* If time to BCR, defined as time to first detectable PSA (\> lower limit of normal for assay used) after RP, is \>= 12 months, a minimum absolute PSA of 0.5 ng/mL is required
* If the patient has a detectable PSA (\> lower limit of normal for assay used) at any time after RP AND has an eligible baseline SOC PET (PET1) with at least one positive lesion in any location, then there is no minimum PSA requirement
* Patients must have no definite evidence for extrapelvic metastatic disease by conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM): if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI for soft tissue lesions and/or a bone scan for osseous lesions
* Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks prior to study registration
* Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC PET scan is completed with an FDA approved radiotracer for prostate cancer after Step 0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0 registration
* Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the prostate bed and pelvic nodes with androgen deprivation therapy (ADT)
* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Patient must not have started ADT for biochemical recurrence prior to baseline PET (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given after baseline study PET/CT but prior to study registration, is permitted as a brief temporizing measure in advance of starting protocol-approved SOC ADT.
* Patient must not be enrolled in another therapeutic clinical trial
* Patient must be able to lie flat and still for approximately 20-30 minutes or otherwise tolerate a PET scan and radiation treatment planning and delivery
* Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI
* Patient must not have history of seizures or known condition that may cause predisposal to seizures (e.g., stroke or head trauma resulting in loss of consciousness) within 1 year prior to registration
* Patient must not have history of inflammatory bowel disease or any gastrointestinal disorder affecting absorption that is expected to increase risk of complication from radiotherapy
* Hemoglobin (Hgb) \>= 9.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0 registration)
* Leukocytes \>= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)
* Absolute neutrophil count \>= 1,500/mcL (obtained within 8 weeks prior to Step 0 registration)
* Platelets \>= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)
* Total bilirubin \< 1.5 x institutional upper limit of normal (ULN) (patients with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, must have a direct bilirubin of \< 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)
* Creatine \< 1.5 x instituional ULN (or measured creatinine clearance \> 30 mL/min)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class I or II (by patient symptoms) or A or B (by objective assessment)
* Patient must not have completed a course of prior pelvic radiation therapy for any reason
* Patient must agree not to father children while on study
* Patient must be English or Spanish speaking to be eligible for the QOL component of the study
* NOTE: Sites cannot translate the associated QOL forms
* STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA
* Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA approved radiotracer with results of extra-pelvic metastases involvement known (positive or negative). The PET1 must have been completed after Step 0 registration and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration
* For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic nodes must be known (positive or negative)
* For patients with positive extra-pelvic metastases (defined as any PET positive lesions outside of standard salvage RT fields \[prostate bed +/- typical whole pelvis\]), the number of extra-pelvic lesions must be known (1 - 5 or \> 5 extra-pelvic lesions) RADIATION: 3-Dimensional Conformal Radiation Therapy, DRUG: Apalutamide, PROCEDURE: Computed Tomography, DRUG: Degarelix, RADIATION: External Beam Radiation Therapy, OTHER: Fluciclovine F18, DRUG: Goserelin Acetate, PROCEDURE: Intensity-Modulated Proton Therapy, RADIATION: Intensity-Modulated Radiation Therapy, DRUG: Leuprolide Acetate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, DRUG: Relugolix, RADIATION: Stereotactic Body Radiation Therapy, DRUG: Triptorelin, RADIATION: Volume Modulated Arc Therapy
Prostate Adenocarcinoma, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8, Biochemically Recurrent Prostate Carcinoma
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Show 342 locations
Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| AdventHealth Littleton Littleton, Colorado | |
| AdventHealth Parker Parker, Colorado | |
| AdventHealth Porter Denver, Colorado | |
| Alaska Breast Care and Surgery LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Oncology and Hematology LLC Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alaska Women's Cancer Care Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Alegent Health Bergan Mercy Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Alegent Health Immanuel Medical Center Omaha, Nebraska | |
| Alegent Health Lakeside Hospital Omaha, Nebraska | |
| Alton Memorial Hospital Alton, Illinois | |
| Anchorage Associates in Radiation Medicine Anchorage, Alaska | Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org) |
| Anchorage Oncology Centre Anchorage, Alaska | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Audie L Murphy VA Hospital San Antonio, Texas | |
| BASS Medical Group - Lennon Walnut Creek, California | |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Baptist Cancer Center-Grenada Grenada, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi | Site Public Contact - (BCCclintrials@bmhcc.org) |
| Bay Area Hospital Coos Bay, Oregon | Site Public Contact - (cherie.cox@bayareahospital.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Bethesda North Hospital Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| CHI Health Good Samaritan Kearney, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Northwest - Spokane South Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Northwest-North Spokane Spokane, Washington | Site Public Contact - (research@ccnw.net) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center at Saint Joseph's Phoenix, Arizona | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (ecog.rss@jimmy.harvard.edu) |
| Central Care Cancer Center - Bolivar Bolivar, Missouri | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Garden City Garden City, Kansas | Site Public Contact - (aroland@kccop.org) |
| Central Care Cancer Center - Great Bend Great Bend, Kansas | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| City of Hope Antelope Valley Lancaster, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Comprehensive Cancer Center Duarte, California | Scott M. Glaser - (sglaser@coh.org) |
| City of Hope Corona Corona, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope South Pasadena South Pasadena, California | Site Public Contact - (becomingapatient@coh.org) |
| City of Hope Upland Upland, California | Site Public Contact - (becomingapatient@coh.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Cooper Hospital University Medical Center Camden, New Jersey | |
| CoxHealth South Hospital Springfield, Missouri | |
| Creighton University Medical Center Omaha, Nebraska | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania | |
| Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania | |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware County Memorial Hospital Drexel Hill, Pennsylvania | |
| Dillon Health Center/Shaw Cancer Center Dillon, Colorado | |
| ECU Health Oncology Kenansville Kenansville, North Carolina | |
| ECU Health Oncology Kinston Kinston, North Carolina | Site Public Contact - (research@ecuhealth.org) |
| ECU Health Oncology Richlands Richlands, North Carolina | |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairbanks Memorial Hospital Fairbanks, Alaska | |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fox Chase Cancer Center Philadelphia, Pennsylvania | |
| Fox Chase Cancer Center - East Norriton Hospital Outpatient Center East Norriton, Pennsylvania | |
| Fox Chase Cancer Center Buckingham Furlong, Pennsylvania | |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Freeman Health System Joplin, Missouri | Site Public Contact - (LJCrockett@freemanhealth.com) |
| Good Samaritan Hospital - Cincinnati Cincinnati, Ohio | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
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Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
Shiva Baghaie, MPH - GUprotocols@alliancenctn.org
NCT06931340
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Inclusion Criteria:
* Documentation of disease:
\* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
* Must have had evidence of metastatic disease (American Joint Committee on Cancer \[AJCC\] metastasis \[M\]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:
* Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR
* Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes \[N\]1, below the aortic bifurcation) will not be eligible for the study; OR
* Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm
* Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria
* No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)
* Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible
* Prior treatment
* ADT (luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration
* No prior chemotherapy for prostate cancer
* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Absolute neutrophil count (ANC) ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate transaminase \[SGT\]) ≤ 1.5 x upper limit of normal (ULN)
* Calculated (Calc.) creatinine clearance \> 30 mL/min
* Serum potassium ≥ 3.5 mmol/L
* Comorbid conditions
* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression
* HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
* Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)
* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible
* Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) \>= 160 mmHg or diastolic BP \>= 100 mmHg despite medical management are not permitted to register
* Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register
* Concomitant medications
* Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information
* Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
* Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information
* Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug DRUG: Androgen Therapy, DRUG: Apalutamide, DRUG: Docetaxel, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Bone Scan, PROCEDURE: PSMA PET Scan, PROCEDURE: Biospecimen Collection, OTHER: Questionnaire Administration
Stage IVB Prostate Cancer AJCC v8, Metastatic Prostate Adenocarcinoma, Castration-Sensitive Prostate Carcinoma
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Show 195 locations
Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Allegheny Valley Hospital Natrona Heights, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| Ascension All Saints Hospital-Spring Street-Racine Racine, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Calumet Hospital-Chilton Chilton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Columbia Saint Mary's Hospital-Milwaukee Campus Milwaukee, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon Mequon, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh Oshkosh, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton Appleton, Wisconsin | Site Public Contact - (AWRI.inquiry@ascension.org) |
| Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield Brookfield, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa Wauwatosa, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Asplundh Cancer Pavilion Willow Grove, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Bayhealth Hospital Kent Campus Dover, Delaware | |
| Bayhealth Hospital Sussex Campus Milford, Delaware | |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Carle BroMenn Medical Center Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Cancer Institute Normal Normal, Illinois | Site Public Contact - (Research@Carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Duke University Medical Center Durham, North Carolina | |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| Eisenhower Medical Center Rancho Mirage, California | |
| FirstHealth of the Carolinas-Moore Regional Hospital Pinehurst, North Carolina | Site Public Contact - (jcwilliams@firsthealth.org) |
| Forbes Hospital Monroeville, Pennsylvania | |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Froedtert and MCW Moorland Reserve Health Center New Berlin, Wisconsin | |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Guthrie Cortland Memorial Hospital Cortland, New York | |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| HaysMed Hays, Kansas | |
| Hematology Oncology Associates of Fredericksburg Inc Fredericksburg, Virginia | Site Public Contact - (cvaughn@hoafredericksburg.com) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Intermountain Medical Center Murray, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Jefferson Cherry Hill Hospital Cherry Hill, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jefferson Methodist Hospital Philadelphia, Pennsylvania | |
| Jefferson Torresdale Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| LDS Hospital Salt Lake City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Logan Health Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Malcom Randall Veterans Administration Medical Center Gainesville, Florida | Site Public Contact - (trials@cancer.ufl.edu) |
| Mary Greeley Medical Center Ames, Iowa | |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McFarland Clinic - Boone Boone, Iowa | |
| McFarland Clinic - Jefferson Jefferson, Iowa | |
| McFarland Clinic - Marshalltown Marshalltown, Iowa | |
| McFarland Clinic - Trinity Cancer Center Fort Dodge, Iowa | |
| MedStar Georgetown University Hospital Washington D.C., District of Columbia | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medstar Washington Hospital Center Washington D.C., District of Columbia | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Sloan Kettering Basking Ridge Basking Ridge, New Jersey | |
| Memorial Sloan Kettering Bergen Montvale, New Jersey | |
| Memorial Sloan Kettering Cancer Center New York, New York | |
| Memorial Sloan Kettering Commack Commack, New York | |
| Memorial Sloan Kettering Monmouth Middletown, New Jersey | |
| Memorial Sloan Kettering Nassau Uniondale, New York | |
| Memorial Sloan Kettering Westchester Harrison, New York | |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital South St Louis, Missouri | Site Public Contact - (Danielle.Werle@mercy.net) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| OSF Saint Francis Hospital and Medical Group Escanaba, Michigan | Site Public Contact - (WI_research_admin@hshs.org) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Rapid City Regional Hospital Rapid City, South Dakota | Site Public Contact - (research@monument.health) |
| Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson Franklin, Wisconsin | Site Public Contact - (AWRI.Inquiry@Ascension.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| Rush MD Anderson Cancer Center Chicago, Illinois | Site Public Contact - (Cancer_Studies@rush.edu) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint George Regional Medical Center St. George, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Saint Luke's Cancer Institute - Boise Boise, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Meridian Meridian, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Luke's Cancer Institute - Nampa Nampa, Idaho | Site Public Contact - (eslinget@slhs.org) |
| Saint Mary's Hospital and Regional Medical Center Grand Junction, Colorado | Site Public Contact - (ccrp@co-cancerresearch.org) |
| Saint Vincent Frontier Cancer Center Billings, Montana | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Salina Regional Health Center Salina, Kansas | Site Public Contact - (mleepers@srhc.com) |
| Sanford Bismarck Medical Center Bismarck, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Broadway Medical Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicTrialsSF@sanfordhealth.org) |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Self Regional Healthcare Greenwood, South Carolina | Site Public Contact - (nmcgaha@selfregional.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sidney Kimmel Cancer Center Washington Township Sewell, New Jersey | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| Stony Brook University Medical Center Stony Brook, New York | |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| ThedaCare Regional Cancer Center Appleton, Wisconsin | Site Public Contact - (ResearchDept@thedacare.org) |
| Thomas Jefferson University Hospital Philadelphia, Pennsylvania | Site Public Contact - (ONCTrialNow@jefferson.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University Health Truman Medical Center Kansas City, Missouri | |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center - Briarcliff Kansas City, Missouri | |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| VCU Health Tappahannock Hospital Tappahannock, Virginia | Site Public Contact - (klcampbell@vcu.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| West Virginia University Charleston Division Charleston, West Virginia | |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
| William S Middleton VA Medical Center Madison, Wisconsin |
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk (EXTRA-PC)
Alexander R Lucas, PhD - Alexander.Lucas@vcuhealth.org
NCT06237179
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Inclusion Criteria:
* Be diagnosed with stage II/III/IV prostate cancer
* Be currently undergoing treatment with ADT (intermittent or prolonged)
* Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
* Be \>40 years of age up to 85;
* Be willing to sign an informed consent with HIPAA authorization form;
* Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
* Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
* Be without any serious medical condition that precludes safe participation in an exercise program;
* Speak English
Exclusion Criteria:
* Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
* Have contraindications to exercise testing;
* Have pre-existing overt cardiovascular disease/heart failure;
* Active illness/infection;
* Hemoglobin \< 7.0 grams/dL
* Platelet count \< 10 x 109/L BEHAVIORAL: Exercise Training Intervention, BEHAVIORAL: Healthy Living Education
Prostate Cancer, Supportive Care
Prostate Cancer, Supportive Care, Exercise
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| Location | Contacts |
|---|---|
| Richmond Veterans Affairs Medical Center Richmond, Virginia | Alexander R Lucas, PhD - (Alexander.Lucas2@va.gov) Alexandra L Marshall, MS - (lara.marshall@vcuhealth.org) |
| Virginia Commonwealth University Massey Cancer Center Richmond, Virginia | Alexandra Marshall - (marshallla@vcu.edu) Alexander Lucas, PhD - (Alexander.Lucas@vcuhealth.org) |
Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With High Risk Prostate Cancer
ctrrecruit@vcu.edu
NCT05946213
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Inclusion Criteria:
* Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of prostate cancer
* High-risk disease defined as having at least one or more of the following:
* cT3a-T3b by digital exam or imaging (American Joint Committee on Cancer \[AJCC\] 8th edition \[Ed.\]) Note: cT4 by imaging or on digital rectal exam is not allowed
* The patient's prostate specific antigen (PSA) value \> 20 ng/mL prior to starting androgen deprivation therapy (ADT) Note: Patients taking a 5-alpha reductase inhibitor (ex finasteride or dutasteride) are eligible The baseline PSA value should be doubled for PSAs taken while on 5-alpha reductase inhibitors
* Gleason Score of 8-10
* Pelvic node positive by conventional imaging with a short axis of at least 1.0 cm
* Prostate gland volume less than 100 cc prior to initiation of ADT as reported at time of biopsy or by separate measure with ultrasound or other imaging modalities including MRI or CT scan
* No definitive clinical or radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI); Negative prostate-specific membrane antigen (PSMA) positron emission tomography (PET) is an acceptable substitute
* Age \>= 18
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* No prior radical prostatectomy
* No prior ablative or focal therapy to the prostate (including, but not limited to, transrectal or transurethral high-intensity focused ultrasound \[HIFU\], laser ablation, cryotherapy, irreversible electroporation \[IRE\], and vascular-targeted photodynamic therapy)
* Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone releasing hormone \[LHRH\] agonist and oral anti-androgen) is =\< 185 days prior to registration; Please note: PSA prior to the start of any ADT will be used to define disease
* No contraindication to prostate MRI (required for planning of radiotherapy in both arms)
* Patients enrolled in NRG-GU009 must be enrolled in NRG-GU013 prior to radiation therapy treatment planning and start of radiation therapy PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, RADIATION: External Beam Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Stereotactic Body Radiation Therapy
Prostate Adenocarcinoma, Stage IVA Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| AMG Crystal Lake - Oncology Crystal Lake, Illinois | Site Public Contact - (advocateresearch@advocate.com) |
| AMG Libertyville - Oncology Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Adams Cancer Center Gettysburg, Pennsylvania | |
| Advocate Christ Medical Center Oak Lawn, Illinois | |
| Advocate Good Samaritan Hospital Downers Grove, Illinois | Site Public Contact - (Barbara.barhamand@advocatehealth.com) |
| Advocate Good Shepherd Hospital Barrington, Illinois | |
| Advocate High Tech Medical Park Palos Heights, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Illinois Masonic Medical Center Chicago, Illinois | |
| Advocate Lutheran General Hospital Park Ridge, Illinois | |
| Advocate Outpatient Center - Aurora Aurora, Illinois | Site Public Contact - (ncorp@aah.org) |
| Advocate Sherman Hospital Elgin, Illinois | |
| Advocate South Suburban Hospital Hazel Crest, Illinois | |
| Alton Memorial Hospital Alton, Illinois | |
| Altru Cancer Center Grand Forks, North Dakota | |
| American Fork Hospital / Huntsman Intermountain Cancer Center American Fork, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Ascension Via Christi Hospitals Wichita Wichita, Kansas | |
| Aspirus Cancer Care - James Beck Cancer Center Rhinelander, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Stevens Point Stevens Point, Wisconsin | Site Public Contact - (Beth.Knetter@aspirus.org) |
| Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin | |
| Aspirus Regional Cancer Center Wausau, Wisconsin | |
| Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John, New Brunswick | |
| Augusta Health Center for Cancer and Blood Disorders Fishersville, Virginia | |
| Aultman Health Foundation Canton, Ohio | Site Public Contact - (ClinicalReserachDept@aultman.com) |
| Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora BayCare Medical Center Green Bay, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Grafton Grafton, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Kenosha South Kenosha, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Racine Racine, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Health Care Germantown Health Center Germantown, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Medical Center in Summit Summit, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Saint Luke's Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora Sinai Medical Center Milwaukee, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Aurora West Allis Medical Center West Allis, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Baptist Health Hardin Elizabethtown, Kentucky | |
| Bay Pines VA Healthcare System Bay Pines, Florida | Site Public Contact - (vhabayresearch@va.gov) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Brigham and Women's Hospital Boston, Massachusetts | |
| Brooke Army Medical Center Fort Sam Houston, Texas | |
| CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec | Site Public Contact - (rechclinique@crchuq.ulaval.ca) |
| CHUM - Centre Hospitalier de l'Universite de Montreal Montreal, Quebec | Site Public Contact - (info.cr.chum@ssss.gouv.qc.ca) |
| CIUSSSEMTL-Hopital Maisonneuve-Rosemont Montreal, Quebec | |
| Camden Clark Medical Center Parkersburg, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Capital Health Medical Center-Hopewell Pennington, New Jersey | Site Public Contact - (clinicaltrials@capitalhealth.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Carlisle Regional Cancer Center Carlisle, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| CarolinaEast Medical Center New Bern, North Carolina | Site Public Contact - (lharrison@carolinaeasthealth.com) |
| Case Western Reserve University Cleveland, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| Castle Medical Center Kailua, Hawaii | |
| Cedars-Sinai Medical Center Los Angeles, California | Site Public Contact - (Cancer.trial.info@cshs.org) |
| Central Maryland Radiation Oncology in Howard County Columbia, Maryland | |
| Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont | |
| Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec | Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca) |
| Chambersburg Hospital Chambersburg, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Clackamas Radiation Oncology Center Clackamas, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Cleveland Clinic Akron General Akron, Ohio | Site Public Contact - (CancerAnswer@ccf.org) |
| Cleveland Clinic Cancer Center Independence Independence, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center Mansfield Mansfield, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center Strongsville Strongsville, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Foundation Cleveland, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Cleveland Clinic Mercy Hospital Canton, Ohio | |
| Cleveland Clinic Wooster Family Health and Surgery Center Wooster, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (Lennette.Gonzales@rwjbh.org) |
| Condell Memorial Hospital Libertyville, Illinois | Site Public Contact - (advocateresearch@advocatehealth.com) |
| Corewell Health Beaumont Troy Hospital Troy, Michigan | |
| Corewell Health Dearborn Hospital Dearborn, Michigan | |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan | |
| Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| Corewell Health William Beaumont University Hospital Royal Oak, Michigan | |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Dartmouth Cancer Center - North Saint Johnsbury, Vermont | Site Public Contact - (cancer.research.nurse@hitchcock.org) |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire | Site Public Contact - (cancer.research.nurse@dartmouth.edu) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Delaware Health Center-Grady Cancer Center Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Doctors Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Dublin Methodist Hospital Dublin, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Duluth Clinic Ashland Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Durham VA Medical Center Durham, North Carolina | Site Public Contact - (VHADURcancertrials@va.gov) |
| Edward Hospital/Cancer Center Naperville, Illinois | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Elmhurst Memorial Hospital Elmhurst, Illinois | Site Public Contact - (Jrohde@emhc.org) |
| Emory Decatur Hospital Decatur, Georgia | Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org) |
| Emory Proton Therapy Center Atlanta, Georgia | Site Public Contact - (allyson.anderson@emory.edu) |
| Emory Saint Joseph's Hospital Atlanta, Georgia | |
| Emory University Hospital Midtown Atlanta, Georgia | |
| Emory University Hospital/Winship Cancer Institute Atlanta, Georgia | |
| Ephrata Cancer Center Ephrata, Pennsylvania | |
| Essentia Health - Deer River Clinic Deer River, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Hibbing Clinic Hibbing, Minnesota | |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin | |
| Essentia Health Saint Mary's Medical Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Sandstone Sandstone, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Virginia Clinic Virginia, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Hayward Clinic Hayward, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health-Spooner Clinic Spooner, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| FHCC at Northwest Hospital Seattle, Washington | |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Farmington Health Center Farmington, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Fred Hutchinson Cancer Center Seattle, Washington | |
| Fresno Cancer Center Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Geisinger Cancer Services-Pottsville Pottsville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Center Danville, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| George Washington University Medical Center Washington D.C., District of Columbia | |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Goshen Center for Cancer Care Goshen, Indiana | Site Public Contact - (cccois@goshenhealth.com) |
| Grady Health System Atlanta, Georgia | |
| Grady Memorial Hospital Delaware, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Grant Medical Center Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Hawaii Cancer Care - Westridge ‘Aiea, Hawaii | Site Public Contact - (info@hawaiicancercare.com) |
| Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii | Site Public Contact - (i.webster@hawaiicancercare.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Hi-Line Sletten Cancer Center Havre, Montana | Site Public Contact - (Roster@nrgoncology.org) |
| Highland Hospital Rochester, New York | |
| Hillcrest Hospital Cancer Center Mayfield Heights, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Huntsman Cancer Institute/University of Utah Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Intermountain Medical Center Murray, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Jersey City Medical Center Jersey City, New Jersey | Site Public Contact - (Roster@nrgoncology.org) |
| Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland | Site Public Contact - (jhcccro@jhmi.edu) |
| Jupiter Medical Center Jupiter, Florida | Site Public Contact - (clinicaltrials@jupitermed.com) |
| Kaiser Permanente Cancer Treatment Center South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Northwest Portland, Oregon | Site Public Contact - (information@kpchr.org) |
| Kaiser Permanente Oakland-Broadway Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Marshall Medical Offices Redwood City, California | |
| Kaiser Permanente- Modesto MOB II Modesto, California | |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Rancho Cordova Cancer Center Rancho Cordova, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kantonsspital Aarau Aarau, | |
| Kapiolani Medical Center for Women and Children Honolulu, Hawaii | |
| LDS Hospital Salt Lake City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Langlade Hospital and Cancer Center Antigo, Wisconsin | Site Public Contact - (Juli.Alford@aspirus.org) |
| Lawrence Memorial Hospital Lawrence, Kansas | Site Public Contact - (Stephanie.Norris@LMH.ORG) |
| Lenox Hill Hospital New York, New York | |
| Lewis and Faye Manderson Cancer Center Tuscaloosa, Alabama | |
| Logan Regional Hospital Logan, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Louis Stokes Cleveland VA Medical Center Cleveland, Ohio | Site Public Contact - (holly.henry@va.gov) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MaineHealth Cancer Care Center of York County Sanford, Maine | |
| MaineHealth Coastal Cancer Treatment Center Bath, Maine | Site Public Contact - (Roster@nrgoncology.org) |
| MaineHealth Maine Medical Center - Portland Portland, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| MaineHealth Maine Medical Center- Scarborough Scarborough, Maine | Site Public Contact - (clinicalresearch@mainehealth.org) |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Mary Bird Perkins Cancer Center Baton Rouge, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Mary Bird Perkins Cancer Center - Gonzales Gonzales, Louisiana | Site Public Contact - (clinicalresearch@marybird.com) |
| Maryland Proton Treatment Center Baltimore, Maryland | Site Public Contact - (info@mdproton.com) |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| McKay-Dee Hospital Center Ogden, Utah | Site Public Contact - (officeofresearch@imail.org) |
| McLeod Regional Medical Center Florence, South Carolina | Site Public Contact - (dorie.sturgill@mcleodhealth.org) |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Mercy Hospital Springfield Springfield, Missouri | |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Miller-Dwan Hospital Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Minnesota Oncology Hematology PA-Chaska Chaska, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Moffitt Cancer Center Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center - McKinley Campus Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at SouthShore Ruskin, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center at Wesley Chapel Wesley Chapel, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Moffitt Cancer Center-International Plaza Tampa, Florida | Site Public Contact - (ClinicalTrials@moffitt.org) |
| Monmouth Medical Center Long Branch, New Jersey | Site Public Contact - (mary.danish@rwjbh.org) |
| Mount Sinai Comprehensive Cancer Center at Aventura Aventura, Florida | Site Public Contact - (yenrique@msmc.com) |
| Mount Sinai Medical Center Miami Beach, Florida | Site Public Contact - (Yvonne.Enriquez@msmc.com) |
| Munson Medical Center Traverse City, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New York-Presbyterian/Brooklyn Methodist Hospital Brooklyn, New York | Site Public Contact - (Adg9003@nyp.org) |
| Newark Beth Israel Medical Center Newark, New Jersey | Site Public Contact - (Christine.Kosmides@rwjbh.org) |
| North Coast Cancer Care Sandusky, Ohio | Site Public Contact - (TaussigResearch@ccf.org) |
| Northern Westchester Hospital Mount Kisco, New York | Site Public Contact - (AMellor@northwell.edu) |
| Northwell Health Cancer Institute at Huntington Greenlawn, New York | |
| Northwell Health Imbert Cancer Center Bay Shore, New York | |
| Northwell Health Physicians Partners Radiation Medicine at Queens Forest Hills, New York | |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Northwest Wisconsin Cancer Center Ashland, Wisconsin | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Oak Brook Oak Brook, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Noyes Memorial Hospital/Myers Cancer Center Dansville, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| OSF Saint Francis Medical Center Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| OhioHealth Mansfield Hospital Mansfield, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| OhioHealth Marion General Hospital Marion, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Ottawa Hospital and Cancer Center-General Campus Ottawa, Ontario | |
| Pali Momi Medical Center ‘Aiea, Hawaii | |
| Pamela Youde Nethersole Eastern Hospital Hong Kong, | |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| PeaceHealth Saint Joseph Medical Center Bellingham, Washington | Site Public Contact - (achapman1@peacehealth.org) |
| Penn State Milton S Hershey Medical Center Hershey, Pennsylvania | Site Public Contact - (CTO@hmc.psu.edu) |
| Phelps Health Delbert Day Cancer Institute Rolla, Missouri | Site Public Contact - (research@phelpshealth.org) |
| Phelps Memorial Hospital Center Sleepy Hollow, New York | |
| ProMedica Flower Hospital Sylvania, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio | Site Public Contact - (PCIOncResearch@promedica.org) |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Queen's Cancer Cenrer - POB I Honolulu, Hawaii | |
| Queen's Cancer Center - Kuakini Honolulu, Hawaii | |
| Queen's Medical Center Honolulu, Hawaii | |
| Reading Hospital West Reading, Pennsylvania | |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Riverside Methodist Hospital Columbus, Ohio | Site Public Contact - (Jennifer.Sexton@ohiohealth.com) |
| Riverton Hospital Riverton, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Rocky Mountain Cancer Centers-Penrose Colorado Springs, Colorado | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Rohnert Park Cancer Center Rohnert Park, California | Site Public Contact - (Kpoct@kp.org) |
| Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey | |
| Rutgers New Jersey Medical School Newark, New Jersey | |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Saint Barnabas Medical Center Livingston, New Jersey | Site Public Contact - (joanne.loeb@rwjbh.org) |
| Saint Charles Health System Bend, Oregon | Site Public Contact - (nosall@stcharleshealthcare.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint George Regional Medical Center St. George, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Saint Joseph Hospital Nashua, New Hampshire | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Hospital East Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Joseph Radiation Oncology Resource Center Lexington, Kentucky | Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org) |
| Saint Luke's Hospital of Duluth Duluth, Minnesota | Site Public Contact - (kdean@slhduluth.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Sandra L Maxwell Cancer Center Cedar City, Utah | Site Public Contact - (officeofresearch@imail.org) |
| Sands Cancer Center Canandaigua, New York | |
| Sanford Joe Lueken Cancer Center Bemidji, Minnesota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford Roger Maris Cancer Center Fargo, North Dakota | Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org) |
| Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota | Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org) |
| Sechler Family Cancer Center Lebanon, Pennsylvania | Site Public Contact - (doxenberg@wellspan.org) |
| Self Regional Healthcare Greenwood, South Carolina | Site Public Contact - (nmcgaha@selfregional.org) |
| Sheboygan Physicians Group Sheboygan, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| South Sacramento Cancer Center Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Springfield Memorial Hospital Springfield, Illinois | Site Public Contact - (pallante.beth@mhsil.com) |
| State University of New York Upstate Medical University Syracuse, New York | |
| Stony Brook University Medical Center Stony Brook, New York | |
| Straub Clinic and Hospital Honolulu, Hawaii | |
| The Cancer Center of Hawaii-Liliha Honolulu, Hawaii | |
| The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky | |
| The Kirklin Clinic at Acton Road Birmingham, Alabama | Site Public Contact - (tmyrick@uab.edu) |
| The New York Hospital Medical Center of Queens Flushing, New York | Site Public Contact - (Roster@nrgoncology.org) |
| The Permanente Medical Group-Roseville Radiation Oncology Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| The Queen's Medical Center - West Oahu ‘Ewa Beach, Hawaii | Site Public Contact - (rohta@queens.org) |
| The Research Institute of the McGill University Health Centre (MUHC) Montreal, Quebec | Site Public Contact - (evelyn.ortega@muhc.mcgill.ca) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| The Valley Hospital - Luckow Pavilion Paramus, New Jersey | Site Public Contact - (clinicaltrialsresearch@valleyhealth.com) |
| Torrance Memorial Physician Network - Cancer Care Torrance, California | Site Public Contact - (courtney.steeneken@tmphysicians.com) |
| Tower Cancer Research Foundation Beverly Hills, California | Site Public Contact - (towercancerresearch@toweroncology.com) |
| Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus Elizabeth, New Jersey | |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UCHealth Highlands Ranch Hospital Highlands Ranch, Colorado | |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCHealth University of Colorado Hospital Aurora, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UH Seidman Cancer Center at Lake Health Mentor Campus Mentor, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UH Seidman Cancer Center at UH Avon Health Center Avon, Ohio | |
| UHHS-Chagrin Highlands Medical Center Beachwood, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie, Maryland | |
| UM Capital Region Medical Center Largo, Maryland | Site Public Contact - (Sarah.Larson@umm.edu) |
| UM Saint Joseph Medical Center Towson, Maryland | Site Public Contact - (Jeanmarie.downing@umm.edu) |
| UM Upper Chesapeake Medical Center Bel Air, Maryland | |
| UPMC Cancer Center - Monroeville Monroeville, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Center at UPMC Horizon Farrell, Pennsylvania | Site Public Contact - (Roster@nrgoncology.org) |
| UPMC Cancer Centers - Arnold Palmer Pavilion Greensburg, Pennsylvania | |
| UPMC Hillman Cancer Center Erie Erie, Pennsylvania | Site Public Contact - (ClinicalResearchServices@upmc.edu) |
| UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion Mechanicsburg, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC Pinnacle Cancer Center/Community Osteopathic Campus Harrisburg, Pennsylvania | Site Public Contact - (klitchfield@PINNACLEHEALTH.org) |
| UPMC-Heritage Valley Health System Beaver Beaver, Pennsylvania | Site Public Contact - (haneydl@upmc.edu) |
| UPMC-Magee Womens Hospital Pittsburgh, Pennsylvania | |
| UPMC-Passavant Hospital Pittsburgh, Pennsylvania | |
| UPMC-Saint Clair Hospital Cancer Center Pittsburgh, Pennsylvania | |
| UPMC-Saint Margaret Pittsburgh, Pennsylvania | |
| UPMC-Shadyside Hospital Pittsburgh, Pennsylvania | |
| UT MD Anderson - League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| UT MD Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| University Hospitals Parma Medical Center Parma, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| University Hospitals Portage Medical Center Ravenna, Ohio | Site Public Contact - (CTUReferral@UHhospitals.org) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arkansas for Medical Sciences Little Rock, Arkansas | |
| University of Hawaii Cancer Center Honolulu, Hawaii | |
| University of Illinois Chicago, Illinois | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Maryland Shore Medical Center at Easton Easton, Maryland | Site Public Contact - (Christina.weisenborn@umm.edu) |
| University of Maryland/Greenebaum Cancer Center Baltimore, Maryland | |
| University of Michigan - Brighton Center for Specialty Care Brighton, Michigan | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Michigan Health - West Wyoming, Michigan | Site Public Contact - (crcwm-regulatory@crcwm.org) |
| University of Michigan Rogel Cancer Center Ann Arbor, Michigan | Site Public Contact - (CancerAnswerLine@med.umich.edu) |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of New Mexico Cancer Center Albuquerque, New Mexico | Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| University of Pittsburgh Cancer Institute (UPCI) Pittsburgh, Pennsylvania | |
| University of Rochester Rochester, New York | |
| University of Utah Sugarhouse Health Center Salt Lake City, Utah | Site Public Contact - (cancerinfo@hci.utah.edu) |
| University of Vermont Medical Center Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Vermont and State Agricultural College Burlington, Vermont | Site Public Contact - (rpo@uvm.edu) |
| University of Washington Medical Center - Montlake Seattle, Washington | |
| University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - Johnson Creek Johnson Creek, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin | Site Public Contact - (clinicaltrials@cancer.wisc.edu) |
| UofL Health Medical Center Northeast Louisville, Kentucky | Site Public Contact - (ctoinfo@louisville.edu) |
| Upstate Cancer Center Radiation Oncology at Oswego Oswego, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Hill Radiation Oncology Syracuse, New York | Site Public Contact - (BinghamE@upstate.edu) |
| Upstate Cancer Center at Oswego Oswego, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Upstate Cancer Center at Verona Verona, New York | Site Public Contact - (McDowelE@upstate.edu) |
| Utah Valley Regional Medical Center Provo, Utah | Site Public Contact - (officeofresearch@imail.org) |
| VCU Massey Cancer Center at Hanover Medical Park Mechanicsville, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Veterans Administration Medical Center-Baltimore Baltimore, Maryland | |
| Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin | Site Public Contact - (ncorp@aurora.org) |
| Washington Hospital Fremont, California | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| WellSpan Health-York Cancer Center York, Pennsylvania | |
| WellSpan Health-York Hospital York, Pennsylvania | |
| West Virginia University Healthcare Morgantown, West Virginia | Site Public Contact - (cancertrialsinfo@hsc.wvu.edu) |
| Westchester Medical Center Valhalla, New York | Site Public Contact - (Roster@nrgoncology.org) |
| Wheeling Hospital/Schiffler Cancer Center Wheeling, West Virginia | |
| Wilcox Memorial Hospital and Kauai Medical Clinic Lihue, Hawaii | |
| Wilmot Cancer Institute at Webster Webster, New York | Site Public Contact - (WCICTOresearch@urmc.rochester.edu) |
| Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin |
Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment (ASCENDE-SBRT)
Wendy Parulekar - wparulekar@ctg.queensu.ca
NCT06235697
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Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months
* Participants with unfavourable risk prostate cancer are eligible according to the following NCCN classification guidelines (Version 4.2022 - May 10, 2022):
• Unfavourable-intermediate risk - has one or more of the following:
* 2 or 3 Intermediate Risk Factors (IRFs): cT2b-cT2c, Gleason 7 (grade group 2 or 3), and/or PSA 10-20 ng/ml;
* Gleason 4+3 (grade group 3)
* \> 50% biopsy cores positive
• High risk - has one of the following:
* cT3a
* Gleason 8-10 (grade group 4 or 5)
* PSA \> 20 ng/ml
• Very-high risk - has at least one of the following:
* cT3b-cT4
* Primary Gleason pattern 5
* 2 or 3 high risk features: cT3a, Gleason 8-10 (grade group 4 or 5), and/or PSA \> 20 ng/ml
* \> 4 cores with Gleason 8-10 (grade group 4 or 5)
* ECOG performance status of 0, 1 or 2
* Participants must be ≥ 18 years of age
* Judged to be medically fit for brachytherapy
* Participant is able (i.e. sufficiently fluent) and willing to complete the quality of life and/or health utility questionnaires in either English, French or Spanish
* Participants consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant must sign a consent form prior to enrollment in the trial to document their willingness to participate
* Participants must be accessible for treatment and follow-up. Investigators must assure themselves the participants enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
* In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of participant enrollment
* Participants must be willing to take precautions to prevent pregnancy while on study
* ADT (LHRH agonists, antagonists, or anti-androgens) for prostate cancer is permitted for up to 30 days before study enrollment
* 5-alpha reductase inhibitors (5-ARI) are allowed, but baseline PSA will be corrected if 5-ARI use occurs within 6 months of enrollment
* Participants may NOT have received other therapies including chemotherapy, PARPi, radioligand or other investigational drugs for prostate cancer
* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Urinary function defined as International Prostate Symptom Score (IPSS) \< 20. Alpha blockers are allowed to treat baseline urinary function
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
Exclusion Criteria:
* Prior pelvic radiotherapy
* Contraindication to radical prostate radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
* Anticoagulation medication (if unsafe to discontinue for gold seed insertion or brachytherapy implant) and/or prior or current bleeding diathesis
* Prior steam vaporization (Rezum), transurethral resection of the prostate (TURP), prostatectomy (simple or radical), or any ablative therapy to the prostate (cryotherapy, HIFU, TULSA, focal laser ablation, photodynamic therapy)
* Prostate volume \> 60cc before start of androgen deprivation therapy
* Anatomy that would preclude precise brachytherapy implant (such as arch interference or large median lobe)
* Evidence of castrate resistance (defined as a rising PSA \> 3.0 ng/ml while testosterone is \< 3.0 nmol/l)
* Hip prosthesis (unilateral hip replacement is allowed if dose constrains can be reasonably achieved. RADIATION: Radiation, RADIATION: Radiation SBRT only, DRUG: ADT
Prostate Cancer
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Study Locations
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| Location | Contacts |
|---|---|
| Allegheny General Hospital Pittsburgh, Pennsylvania | |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| CHUM - Centre Hospitalier de l'Universite de Montreal Montreal, Quebec | Site Public Contact - (info.cr.chum@ssss.gouv.qc.ca) |
| Doctor H. Bliss Murphy Cancer Centre St. John's, Newfoundland and Labrador | |
| Forbes Hospital Monroeville, Pennsylvania | |
| Jefferson Hospital Jefferson Hills, Pennsylvania | Site Public Contact - (ddefazio@wpahs.org) |
| Jewish General Hospital Montreal, Quebec | |
| Kaiser Permanente Cancer Treatment Center South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Downtown Commons Sacramento, California | Site Public Contact - (kpoct@kp.org) |
| Kaiser Permanente Dublin Dublin, California | |
| Kaiser Permanente Fresno Orchard Plaza Fresno, California | |
| Kaiser Permanente Medical Center - Santa Clara Santa Clara, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Medical Center-Vacaville Vacaville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente Oakland-Broadway Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente San Leandro San Leandro, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente- Marshall Medical Offices Redwood City, California | |
| Kaiser Permanente-Deer Valley Medical Center Antioch, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fremont Fremont, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Fresno Fresno, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Modesto Modesto, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Oakland Oakland, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Richmond Richmond, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Roseville Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-San Francisco San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Rosa Santa Rosa, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Santa Teresa-San Jose San Jose, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South Sacramento Sacramento, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-South San Francisco South San Francisco, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Stockton Stockton, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Vallejo Vallejo, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser Permanente-Walnut Creek Walnut Creek, California | Site Public Contact - (Kpoct@kp.org) |
| Kaiser San Rafael-Gallinas San Rafael, California | Site Public Contact - (Kpoct@kp.org) |
| Kingston Health Sciences Centre Kingston, Ontario | Site Public Contact - (cc-clinicaltrials@kgh.kari.net) |
| Lakeridge Health Oshawa Oshawa, Ontario | |
| Lenox Hill Hospital New York, New York | |
| London Regional Cancer Program London, Ontario | |
| Manhattan Eye Ear and Throat Hospital New York, New York | |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Northwell Health/Center for Advanced Medicine Lake Success, New York | |
| Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto, Ontario | |
| Rohnert Park Cancer Center Rohnert Park, California | Site Public Contact - (Kpoct@kp.org) |
| Royal Victoria Regional Health Centre Barrie, Ontario | |
| Saint Vincent Hospital Erie, Pennsylvania | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| The Permanente Medical Group-Roseville Radiation Oncology Roseville, California | Site Public Contact - (Kpoct@kp.org) |
| Trillium Health Partners - Credit Valley Hospital Mississauga, Ontario | |
| University Health Network-Princess Margaret Hospital Toronto, Ontario | Site Public Contact - (clinical.trials@uhn.on.ca) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Waterloo Regional Health Network Kitchener, Ontario | Site Public Contact - (research@wrhn.ca) |
| West Penn Hospital Pittsburgh, Pennsylvania | |
| Wexford Health and Wellness Pavilion Wexford, Pennsylvania | Site Public Contact - (Dawnmarie.DeFazio@ahn.org) |
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer
Bonnie Wettersten, MS - bonnie.wettersten@alessatherapeutics.com
NCT06257693
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Inclusion Criteria:
• Age at least 21 years old
• Histologically confirmed adenocarcinoma of the prostate
• Study participant qualified and planning for radical prostatectomy
• At least 1 prostate lesion measurable by MRI greater or equal to 0.5 cm
• Cohort A and Cohort B: Gleason score 3+4 or higher Cohort C: Gleason score 3+3 with high risk features or 3+4
• Study participant must be willing to undergo post-treatment imaging by MRI
• Participants must be able to understand and sign the informed consent form
• ECOG performance status 0 or 1
• Adequate organ function, including absolute neutrophil count (ANC) ≥1000 cells/μL, hemoglobin ≥9 g/dL, platelets ≥100,000 cells/μL, estimated creatinine clearance ≥50 mL/min, bilirubin \<1.5x ULN (\< 3x ULN for documented Gilbert's syndrome)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and Alkaline phosphatase \<2.5x ULN
• The effects of Enolen on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, men must agree to use a highly effective form of contraception or abstinence at the time of study entry and continuing through three months after radical prostatectomy/implant removal. Highly effective forms of contraception include: Vasectomy Condom with spermicide Partner use of one of the following methods: Postmenopausal \>1 year or age \>55y Bilateral tubal ligation Intrauterine devices (IUDs) Hormonal implants (Implanon, Nexplanon, etc.) Combination oral contraceptives Progestin-only injections (Depo-Provera) Hormonal patches Vaginal Ring Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, the treating physician should be informed immediately.
Exclusion Criteria:
• Prior radiotherapy or surgery for prostate cancer
• Ongoing hormonal therapy for prostate cancer or hormone therapy \<3 months prior to the start of treatment
• Prior prostate procedures such as transurethral resection of the prostate, transurethral microwave thermotherapy of the prostate, high-intensity focused ultrasound or minimally invasive Benign Prostate Hyperplasia (BPH) procedure
• Study participant unwilling or unable to undergo MRI, including participants with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc.
• Metallic hip implant or any other metallic implant or device that distorts the quality of prostatic MR images.
• Study participants who, because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• Presence of any metastatic disease.
• No evidence of extracapsular extension of disease.
• Study participants, who in the opinion of the treating clinician, would be at increased risk of refractory urinary retention due to a transperineal procedure such as the Enolen implant.
• History of prostate infection within 2 years.
• No intercurrent medical condition or circumstances that would preclude prostatectomy.
• History of bleeding diathesis or currently on anti-coagulation therapy that cannot be safely discontinued for implant procedure.
• Any condition that, in the opinion of the Principal Investigator, which would impair the participant's ability to comply with study procedures and undergo prostatectomy.
DRUG: enzalutamide
Prostate Adenocarcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Atlantic Urology Specialists Myrtle Beach, South Carolina | Taylor Stephenson - (taylor.stephenson@startresearch.com) |
| Aurora Urology Milwaukee, Wisconsin | Greg Anderson - (gregory.anderson@aah.org) |
| Mary Bird Cancer Center Metairie, Louisiana | Mandy Shipp - (mshipp@marybird.com) |
| National Institutes of Health Clinical Center Bethesda, Maryland | Katie Evans, RN - (katie.evans@nih.gov) |
| Northwestern University Chicago, Illinois | Sophia Kallas - (sophia.kallas@northwestern.edu) |
| VA Portland Health Care System Portland, Oregon | Laura Onstad - (laura.onstad@va.gov) |
| Virginia Commonwealth University Richmond, Virginia | Genelle Gaudinez - (gaudinezg@vcu.edu) |
Vitamin D for Prostate Endocrine Therapy (ViPER)
Brooke Burgess, MS - URCC_22053@urmc.rochester.edu
NCT05838716
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Inclusion Criteria:
* Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)
* Be age 50 years or older
* Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted)
* Have a total serum vitamin D between 10 and 32 ng/ml
* Have a total serum calcium of less than or equal to 10.5 mg/dl
* Have a normal GFR (glomerular filtration rate \> 30ml)
* Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study
* Be able to provide written informed consent
* Be able to swallow pills and capsules
* Be able to speak and read English
Exclusion Criteria:
* Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment
* Have a diagnosis of stage IV chronic kidney disease
* Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
* Have a history of hypercalcemia or vitamin D toxicity/sensitivity PROCEDURE: Biospecimen Collection, DIETARY_SUPPLEMENT: D Vitamin, PROCEDURE: Dual X-ray Absorptiometry, DRUG: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Stage IVA Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
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Show 51 locations
Study Locations
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| Location | Contacts |
|---|---|
| Adena Regional Medical Center Chillicothe, Ohio | Site Public Contact - (Jeffh@columbusccop.org) |
| Ballad Health Cancer Care - Bristol Bristol, Virginia | Site Public Contact - (charles.mays@balladhealth.org) |
| Ballad Health Cancer Care - Kingsport Kingsport, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Carilion Roanoke Memorial Hospital Roanoke, Virginia | |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| CarolinaEast Medical Center New Bern, North Carolina | Site Public Contact - (lharrison@carolinaeasthealth.com) |
| Community Medical Center Missoula, Montana | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Geisinger Cancer Center Dickson City Dickson City, Pennsylvania | Site Public Contact - (hemoncctrials@geisinger.edu) |
| Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania | Site Public Contact - (HemonCCTrials@geisinger.edu) |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gundersen Lutheran Medical Center La Crosse, Wisconsin | Site Public Contact - (cancerctr@gundersenhealth.org) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Louisiana State University Health Science Center New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Mercy Hospital Saint Louis St Louis, Missouri | |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Nash UNC HealthCare Rocky Mount, North Carolina | |
| Ochsner Medical Center Jefferson New Orleans, Louisiana | Site Public Contact - (Elisemarie.curry@ochsner.org) |
| OptumCare Cancer Care at Charleston Las Vegas, Nevada | Site Public Contact - (research@sncrf.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Regional Cancer Center at Johnson City Medical Center Johnson City, Tennessee | Site Public Contact - (charles.mays@balladhealth.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Saint Francis Cancer Center Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint Francis Hospital Greenville, South Carolina | Site Public Contact - (Heather_Rich@bshsi.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin | Site Public Contact - (WI_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin | Site Public Contact - (wi_research_admin@hshs.org) |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| University Medical Center New Orleans New Orleans, Louisiana | Site Public Contact - (emede1@lsuhsc.edu) |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - Lee's Summit Lee's Summit, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center - North Kansas City, Missouri | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Cancer Center-Overland Park Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial (PREDICT)
Rana McKay, MD - rmckay@health.ucsd.edu
NCT06632977
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Inclusion Criteria:
* PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.
* PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
* PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
* PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
* PRE-REGISTRATION: Age ≥ 18 years.
* REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply):
* PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.
* Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
* Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
* REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
* REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
* REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:
* Chemotherapy-induced neuropathy
* Fatigue
* Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
* REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
* REGISTRATION: No major surgery within 4 weeks of registration.
* REGISTRATION: No prior treatment with EZH inhibitors.
* REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
* REGISTRATION: None of the following conditions:
* Current use of moderate or strong cytochrome P450 (CYP)3A inducers.
* Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Imminent or established spinal cord compression based on clinical and/or imaging findings.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.
* Significant cardiovascular defined as:
* Myocardial infarction within 6 months prior to enrollment.
* Uncontrolled angina pectoris within 6 months prior to enrollment.
* New York Heart Association Class 3 or 4 congestive heart failure.
* Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.
* Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg).
* Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.
* Moderate to severe hepatic impairment (Child-Pugh Class C)
* REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
* REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
* REGISTRATION: No platelet transfusions within 2 weeks of registration.
* REGISTRATION: No bleeding diathesis.
* REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
* REGISTRATION: Hemoglobin ≥ 9 g/dL.
* REGISTRATION: Platelet count ≥ 100,000/mcL.
* REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
* REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \[ULN\] for subjects with documented Gilbert\'s disease).
* REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
* REGISTRATION: Albumin ≥ 2.8 g/dL.
* REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.
* RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).
* RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:
* Chemotherapy-induced neuropathy
* Fatigue
* Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).
* RE-REGISTRATION: None of the following conditions:
* Imminent or established spinal cord compression based on clinical and/or imaging findings.
* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.
* Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.
* Significant cardiovascular defined as:
* Myocardial infarction within 6 months prior to enrollment.
* Uncontrolled angina pectoris within 6 months prior to enrollment.
* New York Heart Association Class 3 or 4 congestive heart failure.
* Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
* RE-REGISTRATION: ECOG Performance Status 0-2.
* RE-REGISTRATION: No GCSF within 2 weeks of registration.
* RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
* RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
* RE-REGISTRATION: WBC ≥ 2,500/mcL.
* RE-REGISTRATION: ANC ≥ 1,500/mcL.
* RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
* RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
* RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
* RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease).
* RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
* RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
* RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
* RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.
Exclusion Criteria:
\- OTHER: Genetic testing, DRUG: Valemetostat Tosylate, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Computed Tomography, PROCEDURE: Bone scan, PROCEDURE: FDG-Positron Emission Tomography, PROCEDURE: PSMA PET Scan, PROCEDURE: Biospecimen Collection, DRUG: Carboplatin, DRUG: Cabazitaxel, DRUG: Abiraterone Acetate, DRUG: Enzalutamide, DRUG: Lutetium Lu 177 Vipivotide Tetraxetan
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
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Show 107 locations
Study Locations
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| Location | Contacts |
|---|---|
| Banner University Medical Center - Tucson Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| Baystate Medical Center Springfield, Massachusetts | Site Public Contact - (tamara.wrenn@baystatehealth.org) |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Bon Secours Cancer Institute at Reynolds Crossing Richmond, Virginia | Site Public Contact - (Anne_caramella@bshsi.org) |
| Bon Secours Memorial Regional Medical Center Mechanicsville, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Richmond Community Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Francis Medical Center Midlothian, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Bon Secours Saint Mary's Hospital Richmond, Virginia | Site Public Contact - (anne_carmellat@bshsi.org) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| Carle Cancer Center Urbana, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Effingham Effingham, Illinois | Site Public Contact - (Research@carle.com) |
| Carle Physician Group-Mattoon/Charleston Mattoon, Illinois | Site Public Contact - (Research@carle.com) |
| Carle at The Riverfront Danville, Illinois | Site Public Contact - (Research@Carle.com) |
| Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota | Site Public Contact - (coborncancercenter@centracare.com) |
| Dana Farber-Merrimack Valley Methuen, Massachusetts | |
| Dana-Farber Cancer Institute Boston, Massachusetts | |
| Dana-Farber Cancer Institute at Foxborough Foxborough, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Milford, Massachusetts | |
| Dana-Farber/Brigham and Women's Cancer Center at South Shore South Weymouth, Massachusetts | |
| Drexel Town Square Health Center Oak Creek, Wisconsin | |
| Edwards Comprehensive Cancer Center Huntington, West Virginia | Site Public Contact - (Christina.Cole@chhi.org) |
| Enloe Medical Center Chico, California | |
| Essentia Health Cancer Center Duluth, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Cancer Center-South University Clinic Fargo, North Dakota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota | Site Public Contact - (CancerTrials@EssentiaHealth.org) |
| Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin | |
| Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin | |
| Gibbs Cancer Center-Gaffney Gaffney, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Gibbs Cancer Center-Pelham Greer, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania | |
| Hackensack University Medical Center Hackensack, New Jersey | |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Jupiter Medical Center Jupiter, Florida | Site Public Contact - (clinicaltrials@jupitermed.com) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | |
| MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri | |
| Marshfield Medical Center-Marshfield Marshfield, Wisconsin | Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org) |
| McFarland Clinic - Ames Ames, Iowa | Site Public Contact - (ksoder@mcfarlandclinic.com) |
| Medical Center of the Rockies Loveland, Colorado | |
| Medical College of Wisconsin Milwaukee, Wisconsin | |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital East Shiloh, Illinois | Site Public Contact - (dschwab@wustl.edu) |
| Memorial Hospital North Colorado Springs, Colorado | |
| MetroHealth Medical Center Cleveland, Ohio | Site Public Contact - (ababal@metrohealth.org) |
| Mount Sinai Hospital New York, New York | Site Public Contact - (CCTO@mssm.edu) |
| Ohio State University Comprehensive Cancer Center Columbus, Ohio | Site Public Contact - (Jamesline@osumc.edu) |
| Oregon Health and Science University Portland, Oregon | Site Public Contact - (trials@ohsu.edu) |
| Parkland Memorial Hospital Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Providence Portland Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Providence Saint Vincent Medical Center Portland, Oregon | Site Public Contact - (CanRsrchStudies@providence.org) |
| Roswell Park Cancer Institute Buffalo, New York | Site Public Contact - (askroswell@roswellpark.org) |
| SMC Center for Hematology Oncology Union Union, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Saint Elizabeth Healthcare Edgewood Edgewood, Kentucky | Site Public Contact - (Kristi.Curtsinger@stelizabeth.com) |
| Saint Elizabeth Healthcare Fort Thomas Fort Thomas, Kentucky | |
| Siteman Cancer Center at Christian Hospital St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center at West County Hospital Creve Coeur, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Siteman Cancer Center-South County St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| Spartanburg Medical Center Spartanburg, South Carolina | Site Public Contact - (kmertz-rivera@gibbscc.org) |
| Stamford Hospital/Bennett Cancer Center Stamford, Connecticut | |
| Swedish Cancer Institute-Edmonds Edmonds, Washington | Site Public Contact - (PCRC-NCORP@Swedish.org) |
| The University of Kansas Cancer Center - Olathe Olathe, Kansas | Site Public Contact - (OlatheCCResearch@kumc.edu) |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Tripler Army Medical Center Honolulu, Hawaii | |
| UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California | Site Public Contact - (ucstudy@uci.edu) |
| UC San Diego Health System - Encinitas Encinitas, California | |
| UC San Diego Medical Center - Hillcrest San Diego, California | Site Public Contact - (rhabbaba@health.ucsd.edu) |
| UC San Diego Moores Cancer Center La Jolla, California | Site Public Contact - (cancercto@ucsd.edu) |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (protocols@AllianceNCTN.org) |
| UCHealth Memorial Hospital Central Colorado Springs, Colorado | |
| UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California | Site Public Contact - (ucstudy@uci.edu) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| UT Southwestern Clinical Center at Richardson/Plano Richardson, Texas | Site Public Contact - (Suzanne.cole@utsouthwestern.edu) |
| UT Southwestern Simmons Cancer Center - RedBird Dallas, Texas | Site Public Contact - (canceranswerline@utsouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth, Texas | Site Public Contact - (canceranswerline@UTSouthwestern.edu) |
| University of Alabama at Birmingham Cancer Center Birmingham, Alabama | Site Public Contact - (gingerreeves@uabmc.edu) |
| University of Arizona Cancer Center-North Campus Tucson, Arizona | Site Public Contact - (UACC-IIT@uacc.arizona.edu) |
| University of California Davis Comprehensive Cancer Center Sacramento, California | |
| University of Iowa Healthcare Cancer Services Quad Cities Bettendorf, Iowa | Site Public Contact - (katherine-daprile@uiowa.edu) |
| University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa | |
| University of Kansas Cancer Center Kansas City, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Health System Saint Francis Campus Topeka, Kansas | |
| University of Kansas Hospital-Indian Creek Campus Overland Park, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Kansas Hospital-Westwood Cancer Center Westwood, Kansas | Site Public Contact - (KUCC_Navigation@kumc.edu) |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Vanderbilt University/Ingram Cancer Center Nashville, Tennessee | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
| West Virginia University Charleston Division Charleston, West Virginia |
Testing Whether the Addition of Carboplatin Chemotherapy to Cabazitaxel Chemotherapy Will Improve Outcomes Compared to Cabazitaxel Alone in People With Castrate-Resistant Prostate Cancer That Has Spread Beyond the Prostate to Other Parts of the Body
ctrrecruit@vcu.edu
NCT06470243
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Inclusion Criteria:
* STEP 1 SCREENING REGISTRATION: NOTE: All participants must have biopsy tissue submitted to MD Anderson Cancer Center prior to randomization for alteration assessment. Participants must have determination of their AVPC-Molecular Pathologic Signature immunohistochemistry (MSIHC) status from central assessment by the MD Anderson Clinical Pathology Laboratory using Clinical Laboratory Improvement Act (CLIA) certified immunohistochemistry (IHC) assays for TP53, RB1 and PTEN. In addition, while not mandated, CLIA certified next generation sequencing (NGS) of tumor deoxyribonucleic acid (DNA) and/or circulating tumor derived DNA (ctDNA) assessment of AVPC-MS marker status will be collected from participants for whom it is available
* STEP 1 SCREENING REGISTRATION: Participants must have a histologically confirmed diagnosis of prostate cancer at the time of step 1 registration
* STEP 1 SCREENING REGISTRATION: Participants must have castrate-resistant prostate cancer and metastatic disease by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node)
* STEP 1 SCREENING REGISTRATION: Participants may have received any prior therapy, but one must be docetaxel or contain docetaxel in either the castrate-sensitive and/or castrate resistant disease state
* STEP 1 SCREENING REGISTRATION: Participants must be ≥ 18 years of age at the time of step 1 screening registration
* STEP 1 SCREENING REGISTRATION: Participants must have solid tumor biopsy material (formalin-fixed paraffin-embedded (FFPE) tissue blocks and/or 10 cut slides on four-micron thick unstained positive charged slides of FFPE tissue) available for submission for alterations in TP53, RB1 and PTEN by IHC using CLIA certified assays in the MD Anderson Clinical Pathology Laboratory. This specimen is required for central assessment of the AVPC-MSIHC regardless of whether the site has already locally evaluated the AVPC-MS status
* STEP 1 SCREENING REGISTRATION: Tumor samples submitted for analysis must have been collected within 12 months prior to step 1 screening registration. Samples from metastatic lesions collected in the castrate-resistant disease state are preferable but not mandatory. Samples obtained during the hormone-naive disease state are acceptable if collected within 12 months of step 1 screening registration. If more than one tumor sample exists, the sample obtained closest to the date of registration should be submitted to MDACC for analysis
* NOTE: Sites will receive an email from Southwest Oncology Group (SWOG) Statistics and Data Management Center containing participant results of Aggressive Variant Prostate Cancer Molecular Signature (AVPC-MS) assessment within 5-12 business days after tissue submission to MD Anderson Clinical Pathology Laboratory. The participant's AVPC-MS signature result (positive or negative) is required BEFORE randomization on to step 2. If sites receive a non-evaluable AVPC-MS signature result, SWOG Statistics and Data Management Center will provide instructions for resubmission
* STEP 1 SCREENING REGISTRATION: NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
* STEP 1 SCREENING REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. Documentation of informed consent via remote consent is allowed
* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
* STEP 2 RANDOMIZATION: NOTE: Participants must be registered to step 2 randomization within 70 days after registration to step 1. Participants must plan to start protocol therapy no more than 14 days after step 2 randomization
* STEP 2 RANDOMIZATION: Participants must have castrate levels of testosterone with a baseline level \< 50ng/dL within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants must have evidence for metastatic prostate cancer by bone scan and/or CT/MRI (i.e., soft tissue, visceral, lymph node). Visceral and/or soft-tissue metastases must be ≥ 1.0 cm in diameter and lymph nodes must be \> 1.5 cm diameter in the short axis. Scans must be obtained within 28 days prior to randomization
* NOTE: All disease must be assessed and documented on the baseline/pre-registration tumor assessment form
* STEP 2 RANDOMZIATION: Participants must have progressive disease (PD) in the opinion of the treating investigator according to any of the following criteria
* Progression in measurable disease (RECIST 1.1 criteria). Patient with measurable disease must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be at least 10 mm when measured by computed tomography (CT) \[CT scan thickness no greater than 5 mm\] or magnetic resonance imaging (MRI). Lymph nodes should be ≥ 15 mm in short axis. Previously irradiated lesions, primary prostate lesion and bone lesions will be considered non-measurable disease
* Progression in bone as evidenced by:
* Appearance of 2 or more new bone lesions on bone scan (BS). If equivocal, they must be confirmed by other imaging modalities (CT; MRI), and/or repeat BS \> 4 weeks later
* Appearance of a new lytic lesion(s) and/or increasing size of an existing lesion by CT/MRI, since AVPC tumors may produce lytic bone lesions that are not detected on conventional bone scans
* Rising prostate-specific antigen (PSA) defined (Prostate Cancer Working Group 2 \[PCWG2\]) as at least two consecutive rises in PSA to be documented over a reference value (measure 1) taken at least one week apart. The first rising PSA (measure 2) should be taken at least 7 days after the reference value. A third confirmatory PSA measure is required (2nd beyond the reference level) to be greater than the second measure and it must be obtained at least 7 days after the 2nd measure. If this is not the case, a fourth PSA measure is required to be taken and be greater than the 2nd measure. In case of progression based on rising PSA only, the first rising PSA (measure 2) must be obtained within 6 months of initiation of androgen receptor (AR) targeted therapy (≤ 6 months)
* Clinical progression. Increasing symptoms unequivocally attributed to disease progression as judged by the treating physician
* STEP 2 RANDOMIZATION: Participants must not have received prior cabazitaxel or carboplatin
* STEP 2 RANDOMIZATION: Participants must not be receiving treatment on another therapeutic clinical trial at the time of randomization. Chemotherapies, bone targeting therapies, immunotherapies and clinical trial agents must be discontinued ≥ 21 days prior to randomization. Stereotactic radiation (SART) must be discontinued ≥ 3 days prior to randomization
* STEP 2 RANDOMIZATION: Participants must not be receiving radiation therapy or kyphoplasty-vertebroplasty within 14 days prior to randomization or major surgery (e.g., open abdominal, pelvic, thoracic, orthopedic or neurosurgery) within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants must not have untreated fractures and/or cord compression
* STEP 2 RANDOMIZATION: Participants must not have symptomatic uncontrolled brain metastases. Properly treated brain metastases (i.e., with stereotactic radiation) within 14 days are allowed
* STEP 2 RANDOMIZATION: Participants must have Zubrod performance status of 0 - 2 within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants must have a complete medical history and physical exam within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Platelets ≥ 100 x 10\^3/uL (unless clinical evidence of bone marrow infiltration by tumor in which case \> 75 x 10\^3/uL are allowed) (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Total bilirubin ≤ institutional upper limit of normal (ULN) with the exception of isolated hyperbilirubinemia due to Gilbert's syndrome or if the participant has liver metastases and/or acute tumor associated illness \< 4x ULN (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (or if participant has liver metastases and/or acute tumor-associated illness, ≤ 4x institutional ULN) (within 28 days prior to step 2 randomization)
* STEP 2 REGISTRATION: Participants must have a calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 randomization
* STEP 2 RANDOMIZATION: Participants with peripheral neuropathy must have ≤ grade 2 peripheral neuropathy (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) (within 28 days prior to step 2 randomization)
* STEP 2 RANDOMIZATION: Participants who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including vasectomy with testing showing no sperm in the semen
* STEP 2 RANDOMIZATION: Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen
* STEP 2 RANDOMIZATION: Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
* STEP 2 RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, DRUG: Cabazitaxel, DRUG: Carboplatin, PROCEDURE: Chest Radiography, PROCEDURE: Computed Tomography, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, DRUG: Prednisone
Castration-Resistant Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
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Study Locations
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| Location | Contacts |
|---|---|
| Abbott-Northwestern Hospital Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Armes Family Cancer Center Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri | |
| Beebe Health Campus Rehoboth Beach, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe Medical Center Lewes, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Beebe South Coastal Health Campus Millville, Delaware | Site Public Contact - (research@beebehealthcare.org) |
| Benefis Sletten Cancer Institute Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Billings Clinic Cancer Center Billings, Montana | Site Public Contact - (research@billingsclinic.org) |
| Billings Clinic-Cody Cody, Wyoming | Site Public Contact - (research@billingsclinic.org) |
| Blanchard Valley Hospital Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Bozeman Health Deaconess Hospital Bozeman, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Cambridge Medical Center Cambridge, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Cancer Care Center of O'Fallon O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Care Specialists of Illinois - Decatur Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Cancer Center of Western Wisconsin New Richmond, Wisconsin | Site Public Contact - (mmcorc@healthpartners.com) |
| Caro Cancer Center Caro, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Centralia Oncology Clinic Centralia, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Christiana Care - Union Hospital Elkton, Maryland | Site Public Contact - (frank.crum@christianacare.org) |
| Christiana Care Health System-Christiana Hospital Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Concord Health Center Chadds Ford, Pennsylvania | Site Public Contact - (lbarone@christianacare.org) |
| Christiana Care Health System-Wilmington Hospital Wilmington, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Community Hospital of Anaconda Anaconda, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Community Medical Center Missoula, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Crossroads Cancer Center Effingham, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Dayton Physician LLC - Englewood Dayton, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC - Troy Troy, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Atrium Franklin, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Miami Valley South Centerville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Dayton Physicians LLC-Wayne Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Decatur Memorial Hospital Decatur, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Lakes Medical Center Wyoming, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Northland Medical Center Princeton, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Fairview Southdale Hospital Edina, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Genesee Cancer and Blood Disease Treatment Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesee Hematology Oncology PC Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Genesys Hurley Cancer Institute Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Great Falls Clinic Great Falls, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Greater Dayton Cancer Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| HSHS Saint Elizabeth's Hospital O'Fallon, Illinois | Site Public Contact - (morganthaler.jodi@mhsil.com) |
| Health Partners Inc Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Helen F Graham Cancer Center Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Hematology Oncology Consultants-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hennepin County Medical Center Minneapolis, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Henry Ford Health Saint John Hospital Detroit, Michigan | Site Public Contact - (Kkeenan1@hfhs.org) |
| Henry Ford Madison Heights Hospital - Breast Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Academic Grosse Pointe Woods, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Henry Ford Saint John Hospital - Breast Grosse Pointe Woods, Michigan | Site Public Contact - (karen.forman@ascension.org) |
| Henry Ford Warren Hospital - Breast Macomb Macomb, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Highlands Oncology Group Springdale, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Fayetteville Fayetteville, Arkansas | Site Public Contact - (research@hogonc.com) |
| Highlands Oncology Group - Rogers Rogers, Arkansas | Site Public Contact - (research@hogonc.com) |
| Holy Cross Hospital Fort Lauderdale, Florida | Site Public Contact - (eileen.georgi@holy-cross.com) |
| Hope Cancer Center Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Hurley Medical Center Flint, Michigan | Site Public Contact - (wstrong@ghci.org) |
| Huron Gastroenterology PC Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Idaho Urologic Institute-Meridian Meridian, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Illinois CancerCare - Washington Washington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Bloomington Bloomington, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Canton Canton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Carthage Carthage, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Dixon Dixon, Illinois | |
| Illinois CancerCare-Eureka Eureka, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Galesburg Galesburg, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Kewanee Clinic Kewanee, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Macomb Macomb, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Ottawa Clinic Ottawa, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Pekin Pekin, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peoria Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Peru Peru, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Illinois CancerCare-Princeton Princeton, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Indu and Raj Soin Medical Center Beavercreek, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kalispell Regional Medical Center Kalispell, Montana | Site Public Contact - (mccinfo@mtcancer.org) |
| Kettering Medical Center Kettering, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Lakeview Hospital Stillwater, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Lyndon Baines Johnson General Hospital Houston, Texas | |
| M D Anderson Cancer Center Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson League City League City, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson West Houston Houston, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in Sugar Land Sugar Land, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| MD Anderson in The Woodlands Conroe, Texas | Site Public Contact - (askmdanderson@mdanderson.org) |
| Medical Oncology Hematology Consultants PA Newark, Delaware | Site Public Contact - (lbarone@christianacare.org) |
| Memorial Hospital of Carbondale Carbondale, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Memorial Medical Center Modesto, California | Site Public Contact - (pallante.beth@mhsil.com) |
| Mercy Hospital Coon Rapids, Minnesota | |
| Mercy Hospital Coon Rapids, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Methodist Medical Center of Illinois Peoria, Illinois | Site Public Contact - (andersonj@illinoiscancercare.com) |
| Michigan Healthcare Professionals Pontiac Pontiac, Michigan | Site Public Contact - (Emily.Crofts@trinity-health.org) |
| Minnesota Oncology - Burnsville Burnsville, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Missouri Baptist Medical Center St Louis, Missouri | |
| Missouri Baptist Sullivan Hospital Sullivan, Missouri | |
| Monticello Cancer Center Monticello, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| MyMichigan Medical Center Saginaw Saginaw, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| MyMichigan Medical Center Tawas Tawas City, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Nebraska Medicine-Bellevue Bellevue, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| Nebraska Medicine-Village Pointe Omaha, Nebraska | |
| New Ulm Medical Center New Ulm, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Newland Medical Associates-Clarkston Clarkston, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Newland Medical Associates-Pontiac Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| North Memorial Medical Health Center Robbinsdale, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Northwestern Medicine Cancer Center Delnor Geneva, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois | Site Public Contact - (Donald.Smith3@nm.org) |
| Northwestern Medicine Glenview Outpatient Center Glenview, Illinois | |
| Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois | |
| Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois | Site Public Contact - (cancertrials@northwestern.edu) |
| Northwestern Medicine Orland Park Orland Park, Illinois | Site Public Contact - (nctnprogram_rhlccc@northwestern.edu) |
| Northwestern University Chicago, Illinois | Site Public Contact - (cancer@northwestern.edu) |
| Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa | |
| Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Oncology Hematology Care Inc-Kenwood Cincinnati, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Orion Cancer Care Findlay, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Parkland Health Center - Farmington Farmington, Missouri | |
| Pocono Medical Center East Stroudsburg, Pennsylvania | Site Public Contact - (Morgan_M.Horton@lvhn.org) |
| Regions Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Reid Health Richmond, Indiana | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Rice Memorial Hospital Willmar, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Ridgeview Medical Center Waconia, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| SIH Cancer Institute Carterville, Illinois | Site Public Contact - (clinical.research@sih.net) |
| Saint Alphonsus Cancer Care Center-Baker City Baker City, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Boise Boise, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Caldwell Caldwell, Idaho | Site Public Contact - (stephanie.couch@stjoeshealth.org) |
| Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Alphonsus Cancer Care Center-Ontario Ontario, Oregon | Site Public Contact - (mccinfo@mtcancer.org) |
| Saint Elizabeth Boardman Hospital Boardman, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Elizabeth Youngstown Hospital Youngstown, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Francis Medical Center Cape Girardeau, Missouri | Site Public Contact - (sfmc@sfmc.net) |
| Saint Francis Regional Medical Center Shakopee, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint John Macomb-Oakland Hospital Warren, Michigan | Site Public Contact - (kforman1@hfhs.org) |
| Saint John's Hospital - Healtheast Maplewood, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| Saint Joseph Warren Hospital Warren, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Saint Mary's Oncology/Hematology Associates of Marlette Marlette, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Saint Mary's Oncology/Hematology Associates of West Branch West Branch, Michigan | Site Public Contact - (lori.srebinski@ascension.org) |
| Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri | |
| Southeast Cancer Center Cape Girardeau, Missouri | |
| Southern Illinois University School of Medicine Springfield, Illinois | |
| Springfield Clinic Springfield, Illinois | |
| The West Clinic - Wolf River Germantown, Tennessee | Site Public Contact - (afletcher@westclinic.com) |
| Tibor Rubin VA Medical Center Long Beach, California | |
| Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Brighton Brighton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Medical Center - Canton Canton, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan | Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org) |
| United Hospital Saint Paul, Minnesota | Site Public Contact - (mmcorc@healthpartners.com) |
| University of Illinois Chicago, Illinois | |
| University of Michigan Health - Sparrow Lansing Lansing, Michigan | Site Public Contact - (harsha.trivedi@umhsparrow.org) |
| University of Mississippi Medical Center Jackson, Mississippi | |
| University of Nebraska Medical Center Omaha, Nebraska | Site Public Contact - (unmcrsa@unmc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| Valley Radiation Oncology Peru, Illinois | |
| Virginia Commonwealth University/Massey Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Wayne Hospital Greenville, Ohio | Site Public Contact - (clinical.trials@daytonncorp.org) |
| Welch Cancer Center Sheridan, Wyoming | Site Public Contact - (mccinfo@mtcancer.org) |
| Western Illinois Cancer Treatment Center Galesburg, Illinois |
Engaging Male Cancer Survivors in Rural Virginia
Cummings, Yvonne - yvonne.cummings@vcuhealth.org
Preston, Michael
14847
HM20014377
Rectum, Colon, Prostate
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Cummings, Yvonne - (yvonne.cummings@vcuhealth.org) |
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (OMAHA-003)
Toll Free Number - Trialsites@msd.com
NCT06136624
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Inclusion Criteria:
* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology.
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before Screening
* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI).
* Has disease that progressed during or after treatment with 1 novel hormonal agent (NHA)
* Has received 1 but no more than 2 taxane-based chemotherapy regimens for metastatic castration-resistant prostate cancer (mCRPC) and has had progressive disease (PD) during or after treatment
* Has ongoing androgen deprivation with serum testosterone \<50 ng/dL (\<1.7 nM)
* Has provided tumor tissue from a fresh core or excisional biopsy from soft tissue not previously irradiated
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
* Has had prior treatment with PARPi or were deemed ineligible to receive treatment by the investigator or have refused PARPi treatment
* Has received prior 177Lu-PSMA-617 or were deemed ineligible to receive 177Lu-PSMA-617 treatment by the investigator or refused 177Lu-PSMA-617 treatment
* Participants who have not received cabazitaxel can be enrolled if they are ineligible for cabazitaxel treatment as determined by the investigator or have refused treatment
* If participant received first generation anti-androgen therapy before screening, the participant has evidence of disease progression \>4 weeks since the last flutamide treatment and \>6 weeks since the last bicalutamide or nilutamide treatment
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses for ≥ 4 weeks before the date of randomization
* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at Screening.
* Participants who can produce sperm must agree to the following during the study treatment period and for at least 7 days after the last dose of opevesostat, for at least 30 days after the last dose of abiraterone acetate, and for at least 3 months after the last dose of enzalutamide: EITHER be abstinent OR must agree to use male condom
Exclusion Criteria:
* Has a gastrointestinal disorder that might affect absorption
* Has a history of pituitary dysfunction
* Has poorly controlled diabetes mellitus
* Has clinically significant abnormal serum potassium or sodium level
* Has a history of active or unstable cardio/cerebro-vascular disease, including thromboembolic events
* Has a history of seizure within 6 months of providing documented informed consent or any condition that may predispose to seizures within 12 months before the date of randomization
* Has a history of clinically significant ventricular arrhythmias
* Has received an anticancer monoclonal antibody (mAb) within 4 weeks before the date of randomization, or has not recovered from adverse events (AEs) due to mAbs administered more than 4 weeks before the date of randomization
* Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, and has not recovered from the toxicities and/or complications
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications
* Has used herbal or medicinal products that may have hormonal anti-prostate cancer activity and/or are known to decrease prostate-specific Antigen (PSA) (eg, saw palmetto, megesterol acetate, citrus pectin polysaccharide) within 4 weeks before the date of randomization
* Has received radium-223 or Lutetium-177 within 4 weeks before the date of randomization, or has not recovered to Grade ≤1 or baseline from AEs due to radium-223 or Lutetium-177 administered more than 4 weeks before the date of randomization
* Has received treatment with 5-αreductase inhibitors (eg, finasteride or dutasteride), estrogens, or cyproterone within 4 weeks before the date of randomization
* Has received colony-stimulating factors within 28 days before the date of randomization
* Has received a whole blood transfusion in the last 120 days before the date of randomization. Packed red blood cells and platelet transfusions are acceptable if not given within 28 days of the date of randomization
* Has received prior targeted small molecule therapy or NHA treatment within 4 weeks before the first dose of study intervention as follows: enzalutamide or apalutamide within 3 weeks or abiraterone acetate + prednisone or darolutamide within 2 weeks
* Has a "superscan" bone scan
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has concurrent active HBV or known active HCV infection
* Has a history of long QTc syndrome
* Has any of the following at Screening Visit: hypotension (systolic BP \<110 mm Hg) or uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP ≥90 mm Hg, in 2 out of 3 recordings with optimized antihypertensive therapy)
* Is unable to swallow capsules/tablets
* Is currently being treated with cytochrome 450-inducing antiepileptic drugs for seizures
* Participants on an unstable dose of thyroid hormone therapy within 6 months before the start of the study intervention
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Systemic use of the following medications within 2 weeks before the first dose of study intervention: strong CYP3A4 inducers (eg, avasimibe, carbamazepine, lumacaftor, phenobarbital, rifampicin, rifapentine, or St John's Wort); P-gp inhibitors (eg, erythromycin, clarithromycin, rifampicin, ketoconazole, itraconazole, posaconazole, artesunate-pyronaridine, ritonavir, indinavir, nelfinavir, atazanavir, glecaprevir-pibrentasvir, simeprevir, ledipasvir-sofosbuvir, verapamil, diltiazem, dronedarone, propafenone, quinidine, cyclosporine, valspodar, or milk thistle \[Silybum marianum\])
* Use of aldosterone antagonist (eg, spironolactone, eplerenone) and phenytoin within 4 weeks before the start of the study intervention DRUG: Opevesostat, DRUG: Abiraterone acetate, DRUG: Enzalutamide, DRUG: Hydrocortisone, DRUG: Fludrocortisone acetate, DRUG: Prednisone, DRUG: Dexamethasone
Prostate Cancer Metastatic
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Study Locations
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| Location | Contacts |
|---|---|
| A. C. Camargo Cancer Center ( Site 0310) São Paulo, São Paulo | |
| AHN Allegheny General Hospital ( Site 0001) Pittsburgh, Pennsylvania | |
| Ad-Vance Medical Research-Research ( Site 1353) Ponce, | |
| Addenbrooke's Hospital ( Site 1605) Cambridge, Cambridgeshire | |
| Affiliated hospital of Jiangnan university ( Site 0434) Wuxi, Jiangsu | |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1477) Uppsala, Uppsala County | |
| Akershus Universitetssykehus-Onkologisk avdeling ( Site 1227) Lørenskog, Akershus | |
| Akita University Hospital ( Site 0904) Akita, | |
| Aliada-Oncologìa ( Site 1257) Lima, | |
| Amsterdam UMC, locatie VUmc ( Site 1156) Amsterdam, North Holland | |
| Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1552) Ankara, | |
| Anschutz Cancer Pavilion ( Site 0046) Aurora, Colorado | |
| Asahikawa Medical University Hospital ( Site 0901) Asahikawa, Hokkaido | |
| Asan Medical Center-Oncology ( Site 1402) Songpagu, Seoul | |
| Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205) Buenos Aires, Buenos Aires F.D. | |
| Atlantic Health System Morristown Medical Center ( Site 0115) Morristown, New Jersey | |
| Avera Cancer Institute - Pierre ( Site 0118) Pierre, South Dakota | |
| Avera Cancer Institute - Yankton ( Site 0117) Yankton, South Dakota | |
| Avera Cancer Institute- Research ( Site 0094) Sioux Falls, South Dakota | |
| Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 0752) Kecskemét, Bács-Kiskun county | |
| Baltimore Veterans Affairs Medical Center ( Site 0069) Baltimore, Maryland | |
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 1554) Adana, | |
| Beijing Cancer hospital-Urinary Surgery ( Site 0395) Beijing, Beijing Municipality | |
| Beijing Friendship Hospital Affiliate of Capital University ( Site 0396) Beijing, Beijing Municipality | |
| Bell Land General Hospital ( Site 0913) Sakai, Osaka | |
| Blue Ridge Cancer Care ( Site 0004) Roanoke, Virginia | |
| Bradford Hill Norte ( Site 0357) Antofagasta, | |
| Bradfordhill-Clinical Area ( Site 0351) Santiago, Region M. de Santiago | |
| Bruce W. Carter Veterans Affairs Medical Center ( Site 0082) Miami, Florida | |
| CIO - Centro de Inmuno-Oncología de Occidente ( Site 1103) Guadalajara, Jalisco | |
| Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 0632) Rennes, Ille-et-Vilaine | |
| Centre Hospitalier Universitaire de Nîmes - Institut de Cancérologie du Gard - Hôpital Universitaire ( Site 0630) Nîmes, Gard | |
| Centre Hospitalier de l'Université de Montréal ( Site 0326) Montreal, Quebec | |
| Centre Hospitalier de la Côte Basque ( Site 0633) Bayonne, Pyrenees-Atlantiques | |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0328) Greenfield Park, Quebec | |
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0629) Clermont-Ferrand, Puy-de-Dome | |
| Centre Oscar Lambret (Site 0634) Lille, Ain | Karim Fizazi - (k-fizazi@o-lambret.fr) |
| Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0327) Québec, Quebec | |
| Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer ( Site 0329) Sherbrooke, Quebec | |
| Centro de Investigacion Clinica de Oaxaca ( Site 1109) Oaxaca City, | |
| Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1302) Bydgoszcz, Kuyavian-Pomeranian Voivodeship | |
| Chang Gung Medical Foundation-Linkou Branch-Medical Oncology ( Site 1504) Taoyuan, | |
| Charing Cross Hospital-Oncology Research ( Site 1606) London, Hammersmith and Fulham | |
| Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0679) Berlin, | |
| China Medical University Hospital-Department of Urology ( Site 1503) Taichung, | |
| Chongqing Three Gorges Central Hospital's ( Site 0426) Chongqing, Chongqing Municipality | |
| Chongqing University Cancer Hospital ( Site 0416) Chongqing, Chongqing Municipality | |
| Chulalongkorn University ( Site 1530) Bangkok, Bangkok | |
| Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 0501) Bogotá, Bogota D.C. | |
| Clinica Universidad Catolica del Maule-Oncology ( Site 0355) Talca, Maule Region | |
| Clinical Research Chile SpA ( Site 0358) Valdivia, Los Ríos Region | |
| Clínica Imbanaco S.A.S ( Site 0509) Cali, Valle del Cauca Department | |
| Clínica Sánchez Ferrer ( Site 1261) Trujillo, La Libertad | |
| Clínica de Neoplasias Litoral ( Site 0305) Itajaí, Santa Catarina | |
| Colorado Clinical Research ( Site 0067) Lakewood, Colorado | |
| Complexo Hospitalario Universitario de Ourense ( Site 1426) Ourense, Orense | |
| Comprehensive Cancer Centers of Nevada ( Site 0010) Las Vegas, Nevada | |
| Cross Cancer Institute ( Site 0332) Edmonton, Alberta | |
| Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 0758) Debrecen, | |
| Dubbo Hospital ( Site 0235) Dubbo, New South Wales | |
| Dunedin Hospital-Southern Blood and Cancers Service ( Site 1203) Dunedin, Otago | |
| ETZ Elisabeth-Internal Medicine ( Site 1160) Tilburg, North Brabant | |
| Ehime University Hospital ( Site 0918) Tōon, Ehime | |
| Emek Medical Center ( Site 0830) Afula, | |
| FALP ( Site 0353) Santiago, Region M. de Santiago | |
| Faculty of Medicine - Khon Kaen University ( Site 1526) Muang, Changwat Khon Kaen | |
| Faculty of Medicine Siriraj Hospital ( Site 1531) Bangkok, Bangkok | |
| Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0555) Olomouc, Olomouc Region | |
| Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0554) Ostrava, Moravian-Silesian Region | |
| Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0551) Prague, Praha 5 | |
| Filios Alta Medicina ( Site 1106) Monterrey, Nuevo León | |
| First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0436) Huaian, Jiangsu | |
| Florida Cancer Specialists - South ( Site 7003) Fort Myers, Florida | |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0877) Milan, Lombardy | |
| Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1151) Schiedam, South Holland | |
| Fred Hutchinson Cancer Center ( Site 0013) Seattle, Washington | |
| Fudan University Shanghai Cancer Center-Urology department ( Site 0376) Shanghai, Shanghai Municipality | |
| Fukushima Medical University Hospital ( Site 0933) Fukushima, | |
| Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 0204) Mendoza, | |
| Fundación Cardiovascular de Colombia ( Site 0503) Piedecuesta, Santander Department | |
| Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1430) Valencia, Valenciana, Comunitat | |
| Fundación Valle del Lili ( Site 0505) Cali, Valle del Cauca Department | |
| Gifu University Hospital ( Site 0910) Gifu, | |
| Greenebaum Comprehensive Cancer Center ( Site 0049) Baltimore, Maryland | |
| Gulhane Egitim Arastirma Hastanesi ( Site 1558) Ankara, | |
| Gustave Roussy ( Site 0626) Villejuif, Val-de-Marne | |
| HELIOS Kliniken Schwerin ( Site 0694) Schwerin, Mecklenburg-Vorpommern | |
| HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 1428) Seville, | |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 1551) Ankara, | |
| Hadassah Medical Center ( Site 0833) Jerusalem, | |
| Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1164) The Hague, South Holland | |
| Henry Ford Hospital ( Site 0015) Detroit, Michigan | |
| Hiroshima University Hospital ( Site 0916) Hiroshima, | |
| Hokkaido University Hospital ( Site 0931) Sapporo, Hokkaido | |
| Hospital Aleman-Oncology ( Site 0207) Buenos Aires, | |
| Hospital Británico de Buenos Aires-Oncology ( Site 0202) Ciudad Autónoma de Buenos Aires, Buenos Aires | |
| Hospital Felicio Rocho ( Site 0317) Belo Horizonte, Minas Gerais | |
| Hospital Jerez de la Frontera ( Site 1427) Jerez de la Frontera, Cadiz | |
| Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 1078) Kuala Lumpur, | |
| Hospital Lucus Augusti-Oncology ( Site 1432) Lugo, | |
| Hospital Mario Penna ( Site 0309) Belo Horizonte, Minas Gerais | |
| Hospital Santa Rita de Cassia-Centro de Pesquisa Clínica ( Site 0320) Vitória, Espírito Santo | |
| Hospital Sultan Ismail ( Site 1081) Johor Bahru, Johor | |
| Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1433) Madrid, Madrid, Comunidad de | |
| Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1431) Madrid, Madrid, Comunidad de | |
| Hospital Universitário Evangélico Mackenzie-Centro de Oncologia Mackenzie ( Site 0314) Curitiba, Paraná | |
| Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0308) Bragança Paulista, São Paulo | |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 0921) Kitakyushu, Fukuoka | |
| Huadong Hospital Affiliated to Fudan University-Urology ( Site 0388) Shanghai, Shanghai Municipality | |
| Hubei Cancer Hospital-Urinary surgery ( Site 0406) Wuhan, Hubei | |
| Hunan Cancer Hospital ( Site 0405) Changsha, Hunan | |
| Hôpital Européen Georges Pompidou ( Site 0628) Paris, | |
| IC La Serena Research ( Site 0356) La Serena, Coquimbo Region | |
| IMAT S.A.S ( Site 0504) Montería, Departamento de Córdoba | |
| INSTITUTO NACIONAL DE ENFERMEDADES NEOPLASICAS-Medical Oncology ( Site 1256) Lima, | |
| IPOR Instituto Peruano de Oncología & Radioterapia-Centro de Investigación ( Site 1254) Lima, | |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 0879) Meldola, Emilia-Romagna | |
| Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0627) Strasbourg, Alsace | |
| Instituto Alexander Fleming-Alexander Fleming ( Site 0206) Buenos Aires, Buenos Aires F.D. | |
| Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 1258) Concepción, Departamento de Junín | |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201) Mar del Plata, Buenos Aires | |
| Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 1555) Istanbul, | |
| James J. Peters VA Medical Center ( Site 0088) The Bronx, New York | |
| Jiangxi Cancer Hospital ( Site 0386) Nanchang, Jiangxi | |
| Kagawa University Hospital ( Site 0917) Kita, Kagawa-ken | |
| Kagoshima University Hospital ( Site 0929) Kagoshima, | |
| Kaiser Permanente Riverside Medical Center ( Site 0099) Riverside, California | |
| Kanazawa Medical University Hospital ( Site 0909) Mukai-awagasaki, Ishikawa-ken | |
| Kansai Medical University Hospital ( Site 0912) Hirakata, Osaka | |
| Karolinska Universitetssjukhuset Solna ( Site 1478) Stockholm, Stockholm County | |
| Klinikum Wels-Grieskirchen GmbH ( Site 0279) Wels, Upper Austria | |
| Kobe University Hospital ( Site 0914) Kobe, Hyōgo | |
| Kuopion Yliopistollinen Sairaala ( Site 0603) Kuopio, Northern Savonia | |
| Kurume University Hospital ( Site 0920) Kurume, Fukuoka | |
| Kyushu University Hospital ( Site 0919) Fukuoka, | |
| M Health Fairview Clinics and Surgery Center ( Site 0019) Minneapolis, Minnesota | |
| MEDICAL COLLEGE OF WISCONSIN ( Site 0020) Milwaukee, Wisconsin | |
| Macquarie University-MQ Health Clinical Trials Unit ( Site 0234) Macquarie University, New South Wales | |
| Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0553) Brno, Brno-mesto | |
| Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1310) Siedlce, Masovian Voivodeship | |
| Meander Medisch Centrum ( Site 1157) Amersfoort, Utrecht | |
| Medical Care and Research SA de CV ( Site 1108) Mérida, Yucatán | |
| Medische Centrum Leeuwarden ( Site 1172) Leeuwarden, Provincie Friesland | |
| Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 0280) Graz, Styria | |
| Meir Medical Center. ( Site 0832) Kfar Saba, | |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 1557) Ankara, | |
| Metro-Minnesota Community Clinical Oncology ( Site 0014) Saint Louis Park, Minnesota | |
| Miyazaki Prefectural Miyazaki Hospital ( Site 0927) Miyazaki, | |
| Nagano Municipal Hospital ( Site 0932) Nagano, | |
| Nanbu Tokushukai Hospital ( Site 0930) Shimajiri, Okinawa | |
| Nanchong Central Hospital-urology ( Site 0422) Nanchong, Sichuan | |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 0377) Nanjing, Jiangsu | |
| Nara Medical University Hospital ( Site 0915) Kashihara, Nara | |
| National Cancer Centre Singapore ( Site 1377) Singapore, Central Singapore | |
| National Cancer Institute ( Site 1079) Putrajaya, Putrajaya | |
| National Cheng Kung University Hospital-Urology ( Site 1502) Tainan, | |
| National Hospital Organization Kumamoto Medical Center ( Site 0924) Kumamoto, | |
| National Hospital Organization Nagasaki Medical Center ( Site 0923) Ōmura, Nagasaki | |
| National Hospital Organization Oita Medical Center ( Site 0925) Ōita, | |
| National Taiwan University Hospital-Urology ( Site 1506) Taipei, | |
| National University Hospital ( Site 1376) Singapore, Central Singapore | |
| Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 1153) Amsterdam, North Holland | |
| Nograd Varmegyei Szent Lazar Korhaz-Onkologia es Sugarterapias Osztaly ( Site 0761) Salgótarján, Nógrád megye | |
| Obras Sociais Irma Dulce ( Site 0302) Salvador, Estado de Bahia | |
| Ochsner Clinic Foundation ( Site 0108) New Orleans, Louisiana | |
| Odense Universitetshospital-Department of oncology ( Site 0579) Odense, Region Syddanmark | |
| Oncosalud-Clinical Research ( Site 1260) Lima, | |
| Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0276) Linz, Upper Austria | |
| Oregon Health and Science University ( Site 0028) Portland, Oregon | |
| Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 0756) Budapest, Pest County | |
| Ospedale San Raffaele-Oncologia Medica ( Site 0876) Milan, | |
| Pan American Center for Oncology Trials - Ciudadela ( Site 1351) San Juan, | |
| Peking University First Hospital-Urology ( Site 0390) Beijing, Beijing Municipality | |
| Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0230) Melbourne, Victoria | |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0354) Santiago, Region M. de Santiago | |
| Prince of Wales Hospital ( Site 0730) Shatin, | |
| Princess Alexandra Hospital-Cancer Care Serices ( Site 0237) Brisbane, Queensland | |
| Princess Margaret Cancer Centre ( Site 0330) Toronto, Ontario | |
| Puerto Rico Medical Research Center LLC ( Site 1354) Hato Rey, | |
| Queen Mary Hospital ( Site 0727) Hong Kong, | |
| Quemex Medical and Research ( Site 1112) Mexico City, Mexico City | |
| Rabin Medical Center ( Site 0828) Petah Tikva, | |
| Radboudumc-Medical Oncology ( Site 1152) Nijmegen, Gelderland | |
| Ralph H. Johnson VA Health Care System (RHJVAHCS)-Urology ( Site 0083) Charleston, South Carolina | |
| Rambam Health Care Campus-Oncology Division ( Site 0826) Haifa, | |
| Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1316) Grudziądz, Kuyavian-Pomeranian Voivodeship | |
| Rigshospitalet ( Site 0576) Copenhagen, Capital Region | |
| Rutgers Cancer Institute of New Jersey ( Site 0033) New Brunswick, New Jersey | |
| SCRI Oncology Partners ( Site 7000) Nashville, Tennessee | |
| Saga-Ken Medical Centre Koseikan ( Site 0922) Saga, Saga-ken | |
| Sahlgrenska Universitetssjukhuset ( Site 1479) Gothenburg, Västra Götaland County | |
| Samsun Medical Park Hastanesi-medical oncology (1560) Samsun, | Dilek Erdem - (dilekgurgenyatagi@yahoo.com) |
| Samsung Medical Center ( Site 1405) Seoul, | |
| Sanatorio Parque ( Site 0208) Rosario, Santa Fe Province | |
| Sapporo Medical University Hospital ( Site 0902) Sapporo, Hokkaido | |
| Sarawak General Hospital-Radiotherapy Unit ( Site 1076) Kuching, Sarawak | |
| Second Affiliated hospital of Anhui Medical University-Urology ( Site 0408) Hefei, Anhui | |
| Seoul National University Hospital-Oncology ( Site 1401) Seoul, | |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1404) Seoul, | |
| Sheba Medical Center ( Site 0827) Ramat Gan, | |
| Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0502) Valledupar, Cesar Department | |
| Songklanagarind hospital ( Site 1527) Hat Yai, Changwat Songkhla | |
| Southwest Hospital of Third Military Medical University ( Site 0420) Chongqing, Chongqing Municipality | |
| Spaarne Gasthuis - Hoofddorp-Oncology ( Site 1170) Hoofddorp, North Holland | |
| St. Olavs Hospital-Kreftklinikken ( Site 1231) Trondheim, Sor-Trondelag | |
| St. Vincent's University Hospital ( Site 0802) Dublin, Dublin | |
| Stanford Cancer Center ( Site 0036) Palo Alto, California | |
| Suining Central Hospital ( Site 0437) Suining, Sichuan | |
| Sun Yat-sen University Cancer Center-Internal medicine ( Site 0413) Guangzhou, Guangdong | |
| Sunnybrook Research Institute ( Site 0331) Toronto, Ontario | |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Onkologii Klinicznej, Dzial Ch ( Site 1318) Kielce, Świętokrzyskie Voivodeship | |
| Sykehuset Østfold Kalnes ( Site 1228) Sarpsborg, Østfold fylke | |
| Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1303) Koszalin, West Pomeranian Voivodeship | |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1553) Istanbul, | |
| Taipei Veterans General Hospital ( Site 1505) Taipei, | |
| Tallaght University Hospital ( Site 0801) Dublin, | |
| Tampereen yliopistollinen sairaala ( Site 0604) Tampere, Pirkanmaa | |
| Tan Tock Seng Hospital-Medical Oncology ( Site 1378) Singapore, Central Singapore | |
| Tauranga Hospital-Bay of Plenty Clinical Trials Unit ( Site 1201) Tauranga, Bay of Plenty | |
| Texas Oncology - Central/South Texas ( Site 8003) Austin, Texas | |
| Texas Oncology - DFW ( Site 8001) Dallas, Texas | |
| Texas Oncology - Gulf Coast ( Site 8002) The Woodlands, Texas | |
| The Beatson West of Scotland Cancer Centre ( Site 1603) Glasgow, Glasgow City | |
| The Christie NHS Foundation Trust ( Site 1608) Manchester, | |
| The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0414) Fuzhou, Fujian | |
| The First Affiliated Hospital of Chongqing Medical University ( Site 0427) Chongqing, Chongqing Municipality | |
| The First Affiliated Hospital of Guangzhou Medical University ( Site 0412) Guangzhou, Guangdong | |
| The First Affiliated Hospital of Ningbo University ( Site 0383) Ningbo, Zhejiang | |
| The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0379) Wenzhou, Zhejiang | |
| The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 0393) Xi'an, Shaanxi | |
| The First Affiliated hospital of Xiamen University-Urology ( Site 0415) Xiamen, Fujian | |
| The First Hospital of Jiaxing-urology ( Site 0380) Jiaxing, Zhejiang | |
| The Jikei University Hospital ( Site 0907) Minato, Tokyo | |
| The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0336) Ottawa, Ontario | |
| The Royal Cornwall Hospital ( Site 1610) Truro, England | |
| The Second Affiliated Hospital Of Kunming Medical University ( Site 0429) Kunming, Yunnan | |
| The Second Affiliated Hospital of Xi'an Jiaotong University ( Site 0394) Xi'an, Shaanxi | |
| The Second Hospital of Tianjin Medical University ( Site 0391) Tianjin, Tianjin Municipality | |
| The Third People's Hospital of Chengdu (CDTPH) ( Site 0428) Chengdu, Sichuan | |
| The University of Osaka Hospital ( Site 0911) Suita, Osaka | |
| Tianjin Medical University Cancer Institute & Hospital ( Site 0392) Tianjin, Tianjin Municipality | |
| Toho University Sakura Medical Center ( Site 0906) Sakura, Chiba | |
| Tongji Hospital Tongji Medical,Science & Technology ( Site 0407) Wuhan, Hubei | |
| Turku University Hospital-Department of Oncology ( Site 0601) Turku, Southwest Finland | |
| Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 0705) Hamburg, | |
| University College London Hospital ( Site 1612) London, London, City of | |
| University Hospitals Cleveland Medical Center ( Site 0043) Cleveland, Ohio | |
| University Malaya Medical Centre ( Site 1077) Lembah Pantai, Kuala Lumpur | |
| University Of Nebraska Medical Center-Oncology/Hematology ( Site 0095) Omaha, Nebraska | |
| University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0040) Orange, California | |
| University of Chicago Medical Center ( Site 0045) Chicago, Illinois | |
| University of Colorado Health - Highlands Ranch Hospital ( Site 0111) Highlands Ranch, Colorado | |
| University of Colorado Health - Lone Tree Medical Center ( Site 0112) Lone Tree, Colorado | |
| University of Illinois at Chicago ( Site 0105) Chicago, Illinois | |
| University of Iowa ( Site 0047) Iowa City, Iowa | |
| University of Kentucky Chandler Medical Center ( Site 0048) Lexington, Kentucky | |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 0051) Miami, Florida | |
| University of Miyazaki Hospital ( Site 0926) Miyazaki, | |
| University of Virginia Health System ( Site 0054) Charlottesville, Virginia | |
| Universitätsklinikum Bonn-Klinik und Poliklinik für Urologie und Kinderurologie ( Site 0680) Bonn, North Rhine-Westphalia | |
| Universitätsklinikum Jena-Klinik und Poliklinik für Urologie ( Site 0682) Jena, Thuringia | |
| Universitätsklinikum Münster - Albert Schweitzer Campus-Klinik für Urologie ( Site 0678) Münster, North Rhine-Westphalia | |
| Universitätsklinikum Schleswig-Holstein-Klinik für Urologie ( Site 0691) Lübeck, Schleswig-Holstein | |
| VA Portland Health Care System ( Site 0058) Portland, Oregon | |
| VCU Health Adult Outpatient Pavillion ( Site 0061) Richmond, Virginia | |
| Vejle Sygehus ( Site 0578) Vejle, Region Syddanmark | |
| VieCuri Medisch Centrum ( Site 1173) Venlo, Limburg | |
| Washington University School of Medicine-Internal Medicine/Oncology ( Site 0062) St Louis, Missouri | |
| West China Hospital, Sichuan University-Urology Surgery ( Site 0417) Chengdu, Sichuan | |
| Westmead Hospital ( Site 0232) Westmead, New South Wales | |
| Wojewodzki Szpital Zespolony im Ludwika Rydygiera w Toruniu ( Site 1304) Torun, Kuyavian-Pomeranian Voivodeship | |
| Xinjiang Medical University Cancer Hospital - Urumqi-Urology ( Site 0419) Ürümqi, Xinjiang | |
| Yale-New Haven Hospital-Yale Cancer Center ( Site 0064) New Haven, Connecticut | |
| Yantai Yuhuangding Hospital ( Site 0397) Yantai, Shandong | |
| Yokohama City University Medical Center ( Site 0908) Yokohama, Kanagawa | |
| Yunnan Province Cancer Hospital ( Site 0418) Kunming, Yunnan | |
| Zachodniopomorskie Centrum Onkologii ( Site 1311) Szczecin, West Pomeranian Voivodeship | |
| Zhejiang Cancer Hospital ( Site 0435) Hangzhou, Zhejiang | |
| Zhejiang Provincial People's Hospital-Urology ( Site 0378) Hangzhou, Zhejiang | |
| Zhongshan Hospital of Fudan University (0430) Shanghai, Shangai | Jianming Guo - (guo.jianming@zs-hospital.sh.cn) |
| Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1163) Sittard-Geleen, Limburg | |
| klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 0696) Munich, Bavaria |
GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
Massey IIT Research Operations - masseyepd@vcu.edu
NCT06636123
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Inclusion Criteria:
* Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor (ARPI) (eg, abiraterone, enzalutamide, apalutamide or darolutamide). Previous prostate-specific membrane antigen (PSMA)-targeted therapy or cytotoxic chemotherapy is allowed but not required.
* Androgen levels ≤50 ng/dL (≤1.73 nmol/L).
* Disease progression following ADT and ARPI treatment described
* PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 days between assessments. PSA levels prior to study enrollment are considered and appropriate for inclusion.
* Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease observed on bone scan.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
* Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening.
* Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL/min
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3.
* Platelets ≥100,000 cells/mm3.
* Serum hemoglobin level ≥8 g/dL.
* Agree to not donate blood or sperm during the study and for 90 days after the last dose of study treatment.
* Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Any investigational agent:
within 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment.
* Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.
* Simultaneous enrollment in any other cancer treatment interventional clinical trial.
* Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.
* Grade ≥3 uncontrolled infection.
* Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment.
* Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment.
* Small cell, anaplastic, or neuroendocrine component.
* Known active brain metastasis.
* Known active leptomeningeal disease.
* Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study treatment unless otherwise noted:
* Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy.
* Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors.
* Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation.
* Inability to swallow medication.
* Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients.
* Known or suspected malabsorption condition or obstruction.
* Active untreated hepatitis B or C" and "Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements DRUG: Investigational Agent Administration
Castration-resistant Prostate Cancer
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Massey CTO GU Team - (masseygu@vcu.edu) |
Detection of Urinary Bladder Cancer Using Raman Spectroscopy-Based Screening of Urine
Guruli, Georgi - georgi.guruli@vcuhealth.org
Guruli, Georgi
12588
HM20006879
Kidney, Other Urinary, Prostate, Bladder, Unknown Sites, Urinary Bladder
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Guruli, Georgi, M.D., Ph.D. - (georgi.guruli@vcuhealth.org) |
The Vanguard Study: Testing a New Way to Screen for Cancer
ctrrecruit@vcu.edu
NCT06995898
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Inclusion Criteria:
* Ages 45-75 years old
* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment
* Agree to allow collection of information from their medical records for study-related purposes
* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic
* Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion
Exclusion Criteria:
* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years
* Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible
* Ongoing cancer diagnostic work-up
* Ongoing participation in another study of an investigational cancer screening test or technology
* Currently breastfeeding or pregnant, or planning to become pregnant in the next year PROCEDURE: Biospecimen Collection, DEVICE: Device Usage, OTHER: Electronic Health Record Review, PROCEDURE: Multi-Cancer Detection Test, PROCEDURE: Multi-Cancer Detection Test, OTHER: Questionnaire Administration
Breast Carcinoma, Bladder Carcinoma, Colorectal Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Lung Carcinoma, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma, Malignant Solid Neoplasm, Liver Carcinoma
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Study Locations
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| Location | Contacts |
|---|---|
| Cancer Care and Hematology-Fort Collins Fort Collins, Colorado | Site Public Contact - (ctsucontact@westat.com) |
| Henry Ford Cancer Institute-Downriver Brownstown, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Health Center - Brownstown Brownstown, Michigan | Site Public Contact - (CDUDAS1@hfhs.org) |
| Henry Ford Health Center - Chesterfield Chesterfield, Michigan | Site Public Contact - (CDUDAS1@hfhs.org) |
| Henry Ford Hospital Detroit, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center Sterling Heights, Michigan | Site Public Contact - (ctsucontact@westat.com) |
| Henry Ford Medical Center - Detroit Northwest Detroit, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Livonia Livonia, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Plymouth Plymouth, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Royal Oak Royal Oak, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center - Troy Troy, Michigan | Site Public Contact - (kkeenan1@hfhs.org) |
| Henry Ford Medical Center-Columbus Novi, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Medical Center-Cottage Grosse Pointe Farms, Michigan | |
| Henry Ford Medical Center-Fairlane Dearborn, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford West Bloomfield Hospital West Bloomfield, Michigan | Site Public Contact - (CTOResearch@hfhs.org) |
| Henry Ford Wyandotte Hospital Wyandotte, Michigan | Site Public Contact - (nhay@hfhs.org) |
| Inova Fair Oaks Hospital Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Inova Schar Cancer Institute Fairfax, Virginia | Site Public Contact - (Stephanie.VanBebber@inova.org) |
| Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii | Site Public Contact - (shelley.a.clark@kp.org) |
| Kaiser Permanente-Division of Research Pleasanton, California | |
| Kaiser Permanente-Franklin Denver, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Lone Tree Lone Tree, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Kaiser Permanente-Rock Creek Lafayette, Colorado | Site Public Contact - (KPCOIHRClinicalResearch@kp.org) |
| Keefe Memorial Hospital Cheyenne Wells, Colorado | Site Public Contact - (cmillsap@keefemh.org) |
| Madigan Army Medical Center Tacoma, Washington | Site Public Contact - (melissa.a.forouhar.mil@health.mil) |
| Medical Center of the Rockies Loveland, Colorado | |
| Poudre Valley Hospital Fort Collins, Colorado | |
| Saint Luke's Hospital of Kansas City Kansas City, Missouri | Site Public Contact - (aroland@kccop.org) |
| Sentara Martha Jefferson Hospital Charlottesville, Virginia | |
| Sentara Norfolk General Hospital Norfolk, Virginia | |
| UCHealth Greeley Hospital Greeley, Colorado | Site Public Contact - (ctsucontact@westat.com) |
| UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina | Site Public Contact - (cancerclinicaltrials@med.unc.edu) |
| University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma | Site Public Contact - (ou-clinical-trials@ouhsc.edu) |
| VCU Community Memorial Health Center South Hill, Virginia | Site Public Contact - (nemer.elmouallem@vcuhealth.org) |
| VCU Massey Cancer Center at Stony Point Richmond, Virginia | Site Public Contact - (ctoclinops@vcu.edu) |
| VCU Massey Comprehensive Cancer Center Richmond, Virginia | Site Public Contact - (CTOclinops@vcu.edu) |
| Walter Reed National Military Medical Center Bethesda, Maryland | |
| Washington University School of Medicine St Louis, Missouri | Site Public Contact - (info@siteman.wustl.edu) |
Longitudinal Cohort Registry of Cancer Survivors
Hong, Susan - susan.hong@vcuhealth.org
Hong, Susan
17880
HM20021510
Leukemia, Not Otherwise Specified, Multiple Myeloma, Mycosis Fungoides, Hodgkin's Lymphoma, Lymphoid Leukemia, Non-Hodgkin's Lymphoma, Soft Tissue, Rectum, Small Intestine, Thyroid, Kaposi's sarcoma, Eye and Orbit, Bones and Joints, Colon, Other Endocrine System, Other Female Genital, Larynx, Corpus Uteri, Lung, Kidney, Other Respiratory and Intrathoracic Organs, Any Site, Other Male Genital, Leukemia, other, Other Skin, Esophagus, Anus, Brain and Nervous System, Other Urinary, Myeloid and Monocytic Leukemia, Other Digestive Organ, Prostate, Melanoma, skin, Lip, Oral Cavity and Pharynx, Liver, Pancreas, Other Hematopoietic, Ill-Defined Sites, Ovary, Stomach, Breast, Urinary Bladder, Cervix
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| Location | Contacts |
|---|---|
| Virginia Commonwealth University Richmond, Virginia | Hong, Susan - (susan.hong@vcuhealth.org) |