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9 Study Matches

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial (INNOVATE)

Loney, Shenise - loneys2@vcu.edu

Urdaneta, Alfredo, I
NCT04134260
HM20021914
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Inclusion Criteria:
* Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted * Any T-stage is eligible (American Joint Committee on Cancer \[AJCC\] 8th edition \[ed\]) * Appropriate stage for study entry based on fluciclovine F-18 PET scan (FACBC, Axumin) F-18 prostate-specific membrane antigen (PSMA) PET (PyLarify) scan, Gallium-68 PSMA PET scan, flotufolastat F-18 PSMA PET scan (Posluma), or C-11 or F-18 Choline PET within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease. For patients with PSA \< 0.20 ng/mL at time of registration, PET scan is recommended but not required * Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen or nodal disease on imaging at time of recurrence (including external iliacs, internal iliacs, and/or obturator nodes); peri-prostatic and peri-rectal nodes can also be considered regional lymphadenopathy and are allowed * History/physical examination within 90 days prior to registration * Age \>= 18 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration * Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA \> 0 ng/mL at least 30 days after prostatectomy * Patients who have already started on post-prostatectomy GnRH agonist/antagonist for =\< 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started =\< 180 days and stopped prior to registration) * Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration) * Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration) * Serum potassium \>= 3.5 mmol/L within 90 days prior to registration * Creatinine clearance (CrCl) \>= 30 mL/min estimated by Cockcroft-Gault (please use actual weight for calculation unless greater than 30% above ideal body weight then use the adjusted body weight) (within 90 days prior to registration) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject is eligible) (within 90 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (within 90 days prior to registration) * Serum albumin \>= 3.0 g/dL (within 90 days prior to registration) * Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to registration * The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count \>= 200 cells/microliter within 30 days prior to registration. Note: HIV testing is not required for eligibility for this protocol * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol * 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 within 30 days prior to registration * 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. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ) who has no evidence of disease for \< 3 years must contact the principal investigator, Ronald Chen, Doctor of Medicine (MD) * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
* Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. Fluciclovine F-18 PET, \[FACBC, Axumin\], F-18 PSMA PET \[Pylarify\], flotufolastat F-18 PSMA PET scan \[Posluma\], Gallium-68 PSMA PET scan or C-11 choline PET) * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed \> 3 years prior to registration) * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Androgen deprivation therapy (ADT) prior to radical prostatectomy * Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =\< 180 days and stopped prior to registration, which is allowed * Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible * History of any of the following: * Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system \[CNS\] or meningeal disease which may require treatment with surgery or radiation therapy) * Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration * New York Heart Association functional classification III/IV (Note: 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.) * History of any condition that in the opinion of the investigator, would preclude participation in this study * Current evidence of any of the following: * Known gastrointestinal disorder affecting absorption of oral medications * Active uncontrolled infection * Presence of uncontrolled hypertension (persistent systolic blood pressure \[BP\] \>= 160 mmHg or diastolic BP \>= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment * Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily * Baseline moderate and severe hepatic impairment (Child-Pugh Class B \& C) * Inability to swallow oral pills * Any current condition that in the opinion of the investigator, would preclude participation in this study * Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study * Patients with inflammatory bowel disease
DRUG: Apalutamide, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, DRUG: Hormone Therapy, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy
Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Prostate Cancer, Apalutamide, Abiraterone Acetate
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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)
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
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Audie L Murphy VA Hospital San Antonio, Texas
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)
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute - Mitchell Mitchell, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Pierre Pierre, South Dakota Site Public Contact - (OncRegulatory@avera.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)
Bellin Memorial Hospital Green Bay, Wisconsin
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 Saint Francis Medical Center Midlothian, Virginia Site Public Contact - (anne_carmellat@bshsi.org)
Brigham and Women's Hospital Boston, Massachusetts
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CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Québec, Quebec Site Public Contact - (rechclinique@crchuq.ulaval.ca)
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)
Cancer Partners of Nebraska Lincoln, Nebraska Site Public Contact - (research@cancerpartners.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 - (Roster@nrgoncology.org)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Chester County Hospital West Chester, Pennsylvania Site Public Contact - (carolann.hoppes@pennmedicine.upenn.edu)
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)
Cleveland Clinic Akron General Akron, Ohio Site Public Contact - (CancerAnswer@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 Wooster Family Health and Surgery Center Wooster, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Coborn Cancer Center at Saint Cloud Hospital Saint Cloud, Minnesota Site Public Contact - (coborncancercenter@centracare.com)
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
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Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Cooper Hospital University Medical Center Camden, New Jersey
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Crozer Regional Cancer Center at Brinton Lake Glen Mills, Pennsylvania
Crozer-Chester Medical Center Upland, Pennsylvania
Crozer-Keystone Regional Cancer Center at Broomall Broomall, Pennsylvania
Dana-Farber Cancer Institute Boston, Massachusetts
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware County Memorial Hospital Drexel Hill, Pennsylvania
Drexel Town Square Health Center Oak Creek, Wisconsin
Duke Cancer Center Cary Cary, North Carolina Site Public Contact - (NCTNStudyTeam@dm.duke.edu)
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Duke University Medical Center Durham, North Carolina
East Jefferson General Hospital Metairie, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Edward Hospital/Cancer Center Naperville, Illinois
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Decatur Hospital Decatur, Georgia Site Public Contact - (clinicaltrialsoncology@dekalbmedical.org)
Emory Johns Creek Hospital Johns Creek, Georgia Site Public Contact - (m.lisa.hwang@emory.edu)
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
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)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Froedtert Menomonee Falls Hospital Menomonee Falls, Wisconsin
Froedtert West Bend Hospital/Kraemer Cancer Center West Bend, Wisconsin
Garnet Health Medical Center Middletown, New York Site Public Contact - (jgerlach@garnethealth.org)
George Washington University Medical Center Washington D.C., District of Columbia
Grady Health System Atlanta, Georgia
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.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 Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Highland Hospital Rochester, New York
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
IRMC Cancer Center Indiana, Pennsylvania Site Public Contact - (haneydl@upmc.edu)
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)
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Iowa Lutheran Hospital Des Moines, Iowa
Iowa Methodist Medical Center Des Moines, Iowa
Kaiser Permanente - Panorama City Panorama City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente Los Angeles Medical Center Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente South Bay Harbor City, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente West Los Angeles Los Angeles, California Site Public Contact - (clinical.trials@kp.org)
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Kaiser Permanente-Bellflower Bellflower, California Site Public Contact - (clinical.trials@kp.org)
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Kaiser Permanente-Irvine Irvine, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Ontario Ontario, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Riverside Riverside, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Diego Zion San Diego, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-San Marcos San Marcos, California Site Public Contact - (clinical.trials@kp.org)
Kaiser Permanente-Woodland Hills Woodland Hills, California Site Public Contact - (clinical.trials@kp.org)
Karmanos Cancer Institute at McLaren Greater Lansing Lansing, Michigan
LSU Health Baton Rouge-North Clinic Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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
Los Angeles General Medical Center Los Angeles, California
Loyola University Medical Center Maywood, Illinois
MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey
MU Health - University Hospital/Ellis Fischel Cancer Center Columbia, Missouri
Marin General Hospital Greenbrae, California
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bird Perkins Cancer Center Baton Rouge, Louisiana Site Public Contact - (clinicalresearch@marybird.com)
Mary Bird Perkins Cancer Center - Metairie Metairie, Louisiana
Massachusetts General Hospital Cancer Center Boston, Massachusetts
McFarland Clinic - Ames Ames, Iowa Site Public Contact - (ksoder@mcfarlandclinic.com)
McLaren Cancer Institute-Flint Flint, Michigan
McLaren Cancer Institute-Macomb Mount Clemens, Michigan
McLaren Cancer Institute-Owosso Owosso, Michigan
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 Sloan Kettering Basking Ridge Basking Ridge, New Jersey
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Memorial Sloan Kettering Cancer Center New York, New York
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Memorial Sloan Kettering Nassau Uniondale, New York
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
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Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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Mercy Oncology and Hematology - Clayton-Clarkson Ballwin, Missouri
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Methodist West Hospital West Des Moines, Iowa
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
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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)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
New Hampshire Oncology Hematology PA-Concord Concord, New Hampshire
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NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
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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 Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Francis Medical Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Francis Radiation Oncology at Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Las Vegas - Henderson Henderson, Nevada
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OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
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Our Lady of the Lake Physician Group Baton Rouge, Louisiana Site Public Contact - (research@ololrmc.com)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Memorial Hospital Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
Penn State Milton S Hershey Medical Center Hershey, Pennsylvania Site Public Contact - (CTO@hmc.psu.edu)
Premier Blood and Cancer Center Dayton, Ohio
Queens Cancer Center Rego Park, New York
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Radiation Oncology Centers of Nevada Southeast Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Reading Hospital West Reading, Pennsylvania
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Reid Health Richmond, Indiana Site Public Contact - (clinical.trials@daytonncorp.org)
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Ridgeview Medical Center Waconia, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Ridley-Tree Cancer Center Santa Barbara, California
Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
Rush MD Anderson Cancer Center Chicago, Illinois
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Rutgers New Jersey Medical School Newark, New Jersey
Saint Anthony Regional Hospital Carroll, Iowa Site Public Contact - (sbenson@iora.org)
Saint Barnabas Medical Center Livingston, New Jersey Site Public Contact - (joanne.loeb@rwjbh.org)
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Saint Luke's Hospital Chesterfield, Missouri
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Sands Cancer Center Canandaigua, New York
Singh and Arora Hematology Oncology PC Flint, Michigan
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
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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
Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
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Location Contacts
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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 Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Lakeside Hospital Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alton Memorial Hospital Alton, Illinois
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska
Ascension Saint Mary's Hospital Saginaw, Michigan Site Public Contact - (Beth.Knetter@aspirus.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
Audie L Murphy VA Hospital San Antonio, Texas
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 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 Site Public Contact - (aroland@kccop.org)
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 Toms River, New Jersey Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Toms River, New Jersey 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 Site Public Contact - (Jolene.garney@crozer.org)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware County Memorial Hospital Drexel Hill, Pennsylvania Site Public Contact - (jolene.garney@crozer.org)
Delbert Day Cancer Institute at PCRMC Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
ECU Health Oncology Kenansville Kenansville, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Kinston Kinston, North Carolina Site Public Contact - (research@ecuhealth.org)
ECU Health Oncology Richlands Richlands, North Carolina Site Public Contact - (research@ecuhealth.org)
FHCC South Lake Union Seattle, Washington
FHCC at Northwest Hospital Seattle, Washington
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 Site Public Contact - (ecog.rss@jimmy.harvard.edu)
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)
Good Samaritan Regional Health Center Mount Vernon, Illinois
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)
Hackensack University Medical Center Hackensack, New Jersey
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (linda.schumacher@mymlc.com)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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)
Jewish Hospital Louisville, Kentucky
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Kalispell Regional Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, 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)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver, Washington
Legacy Good Samaritan Hospital and Medical Center Portland, Oregon
Legacy Meridian Park Hospital Tualatin, Oregon
Legacy Mount Hood Medical Center Gresham, Oregon
Legacy Salmon Creek Hospital Vancouver, Washington
Lenox Hill Hospital New York, New York
Littleton Adventist Hospital Littleton, Colorado
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Los Angeles General Medical Center Los Angeles, California Site Public Contact - (uscnorrisinfo@med.usc.edu)
Loyola University Medical Center Maywood, Illinois
MD Anderson Cancer Center at Cooper-Voorhees Voorhees Township, New Jersey
MU Health Care Goldschmidt Cancer Center Jefferson City, Missouri
Maine Medical Center- Scarborough Campus Scarborough, Maine
Maine Medical Center-Bramhall Campus Portland, Maine
Maine Medical Partners - South Portland South Portland, Maine
MaineHealth Cancer Care Center of York County Sanford, Maine
MaineHealth Coastal Cancer Treatment Center Bath, Maine
MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford, Maine
MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford, Maine
Manhattan Eye Ear and Throat Hospital New York, New York
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
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 Cancer Center Merced, California
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Clinic-Rolla-Cancer and Hematology Rolla, Missouri
Mercy Hospital Coon Rapids, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Fort Smith Fort Smith, Arkansas
Mercy Hospital Joplin Joplin, Missouri Site Public Contact - (esmeralda.carrillo@mercy.net)
Mercy Hospital Oklahoma City Oklahoma City, Oklahoma
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Methodist Medical Center of Illinois Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
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)
Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mission Hope Medical Oncology - Santa Maria Santa Maria, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, 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-International Plaza Tampa, Florida Site Public Contact - (ClinicalTrials@moffitt.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Monticello Cancer Center Monticello, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mount Sinai Chelsea New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Union Square New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai West New York, New York Site Public Contact - (CCTO@mssm.edu)
North Memorial Medical Health Center Robbinsdale, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Northwell Health Imbert Cancer Center Bay Shore, New York
Northwell Health/Center for Advanced Medicine Lake Success, New York
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 University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
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Phelps Memorial Hospital Center Sleepy Hollow, New York
Porter Adventist Hospital Denver, Colorado
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Cancer Institute Clackamas Clinic Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
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Providence Saint Mary Regional Cancer Center Walla Walla, Washington Site Public Contact - (Cheryl.Dodd@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Rice Memorial Hospital Willmar, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
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Robert Wood Johnson University Hospital Somerset Somerville, New Jersey Site Public Contact - (Siby.Varughese@rwjbh.org)
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Rush - Copley Medical Center Aurora, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
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Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
SIH Cancer Institute Carterville, Illinois Site Public Contact - (clinical.research@sih.net)
Saint Alphonsus Cancer Care Center-Boise Boise, Idaho Site Public Contact - (stephanie.couch@stjoeshealth.org)
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Sainte Genevieve County Memorial Hospital Sainte Genevieve, Missouri
Sanford Cancer Center Oncology Clinic Sioux Falls, South Dakota
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota
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Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
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Southern Illinois University School of Medicine Springfield, Illinois
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Western Illinois Cancer Treatment Center Galesburg, Illinois
William S Middleton VA Medical Center Madison, Wisconsin
Woodland Memorial Hospital Woodland, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)

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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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 III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.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 Site Public Contact - (research@viachristi.org)
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
CHUM - Centre Hospitalier de l'Universite de Montreal Montreal, Quebec
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
Central Maryland Radiation Oncology in Howard County Columbia, Maryland
Central Vermont Medical Center/National Life Cancer Treatment Berlin Corners, Vermont
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 Toms River, New Jersey 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)
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)
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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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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)
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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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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)

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
Bladder Carcinoma, Breast Carcinoma, Colorectal Carcinoma, Esophageal Carcinoma, Gastric Carcinoma, Liver Carcinoma, Lung Carcinoma, Malignant Solid Neoplasm, Ovarian Carcinoma, Pancreatic Carcinoma, Prostate Carcinoma
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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 Detroit, 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)
Medical Center of the Rockies Loveland, Colorado
Poudre Valley Hospital Fort Collins, Colorado
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)
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)

Distress in the Pediatric Oncology Setting: Intervention versus Natural Adaptation

Jewell, Andrea - Andrea.Jewell@vcuhealth.org

Rohan, Jennifer
NCT04409301
HM20019000
Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Breast, Brain and Nervous System, Bones and Joints, Anus, Any Site, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Female Genital, Other Endocrine System, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Urinary, Other Skin, Other Respiratory and Intrathoracic Organs, Other Male Genital, Other Hematopoietic
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Virginia Commonwealth University Richmond, Virginia Jewell, Andrea - (Andrea.Jewell@vcuhealth.org)

Longitudinal Cohort Registry of Cancer Survivors

Hong, Susan - susan.hong@vcuhealth.org

Hong, Susan
17880
HM20021510
Anus, Any Site, Bones and Joints, Breast, Brain and Nervous System, Other Hematopoietic, Other Female Genital, Other Endocrine System, Other Digestive Organ, Non-Hodgkin's Lymphoma, Myeloid and Monocytic Leukemia, Mycosis Fungoides, Multiple Myeloma, Melanoma, skin, Lymphoid Leukemia, Lung, Liver, Lip, Oral Cavity and Pharynx, Leukemia, other, Leukemia, Not Otherwise Specified, Larynx, Kidney, Kaposi's sarcoma, Ill-Defined Sites, Hodgkin's Lymphoma, Eye and Orbit, Esophagus, Corpus Uteri, Colon, Cervix, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Urinary, Urinary Bladder, Thyroid, Stomach, Soft Tissue, Small Intestine, Rectum, Prostate, Pancreas, Ovary, Other Skin
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Virginia Commonwealth University Richmond, Virginia Hong, Susan - (susan.hong@vcuhealth.org)