RECRUITING

Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer

Conditions

Prostate Adenocarcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage IIA Prostate Cancer AJCC v8 Stage IIB Prostate Cancer AJCC v8 Stage IIC Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 Stage IIIA Prostate Cancer AJCC v8 Stage IIIB Prostate Cancer AJCC v8 Stage IIIC Prostate Cancer AJCC v8 Stage IVA Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

Official Title

Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging Into Salvage Treatment for Patients With Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying Treatment for NOde Positive Prostate Cancer by VArying the Hormonal ThErapy

Quick Facts

Study Start:2020-03-05

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04134260

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 positron emission tomography (PET) scan (FACBC, Axumin) within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease; Note that though every effort should be made to obtain a fluciclovine F-18 PET (FACBC, Axumin) scan; however, if the patient has already had a recent F-18 PSMA PET (PyLarify) scan or gallium Ga 68-labeled PSMA-11 (Ga-68 PSMA) PET scan or C-11 or F-18 choline PET scan within 90 days prior to registration (to include scan report) then repeat molecular imaging with a fluciclovine F-18 PET (FACBC, Axumin) scan will not be required. * Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (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 * 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 and within 180 days of registration and before start of GnRH agonist/antagonist * 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	* Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11) * 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

Inclusion Criteria

Exclusion 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 positron emission tomography (PET) scan (FACBC, Axumin) within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease; Note that though every effort should be made to obtain a fluciclovine F-18 PET (FACBC, Axumin) scan; however, if the patient has already had a recent F-18 PSMA PET (PyLarify) scan or gallium Ga 68-labeled PSMA-11 (Ga-68 PSMA) PET scan or C-11 or F-18 choline PET scan within 90 days prior to registration (to include scan report) then repeat molecular imaging with a fluciclovine F-18 PET (FACBC, Axumin) scan will not be required.
* Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (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
* 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 and within 180 days of registration and before start of GnRH agonist/antagonist
* 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

* Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11)
* 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

Contacts and Locations

Principal Investigator

Ronald C Chen

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Kaiser Permanente-Anaheim

Anaheim, California, 92806

United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706

United States

Kaiser Permanente-Bellflower

Bellflower, California, 90706

United States

Mercy Cancer Center - Carmichael

Carmichael, California, 95608

United States

Mercy San Juan Medical Center

Carmichael, California, 95608

United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758

United States

Kaiser Permanente-Fontana

Fontana, California, 92335

United States

Marin General Hospital

Greenbrae, California, 94904

United States

Kaiser Permanente South Bay

Harbor City, California, 90710

United States

Kaiser Permanente-Irvine

Irvine, California, 92618

United States

Tibor Rubin VA Medical Center

Long Beach, California, 90822

United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034

United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

United States

Kaiser Permanente-Ontario

Ontario, California, 91761

United States

Kaiser Permanente - Panorama City

Panorama City, California, 91402

United States

Kaiser Permanente-Riverside

Riverside, California, 92505

United States

Mercy Cancer Center - Rocklin

Rocklin, California, 95765

United States

Mercy Cancer Center - Sacramento

Sacramento, California, 95816

United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

United States

Kaiser Permanente-San Diego Zion

San Diego, California, 92120

United States

UCSF Medical Center-Mount Zion

San Francisco, California, 94115

United States

UCSF Medical Center-Parnassus

San Francisco, California, 94143

United States

UCSF Medical Center-Mission Bay

San Francisco, California, 94158

United States

Kaiser Permanente-San Marcos

San Marcos, California, 92078

United States

Ridley-Tree Cancer Center

Santa Barbara, California, 93105

United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367

United States

Woodland Memorial Hospital

Woodland, California, 95695

United States

Beebe South Coastal Health Campus

Millville, Delaware, 19967

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718

United States

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

United States

George Washington University Medical Center

Washington, District of Columbia, 20037

United States

Tampa General Hospital

Tampa, Florida, 33606

United States

Grady Health System

Atlanta, Georgia, 30303

United States

Emory Proton Therapy Center

Atlanta, Georgia, 30308

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097

United States

Alton Memorial Hospital

Alton, Illinois, 62002

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Northwestern University

Chicago, Illinois, 60611

United States

Rush University Medical Center

Chicago, Illinois, 60612

United States

University of Illinois

Chicago, Illinois, 60612

United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, 60115

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, 60134

United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Condell Memorial Hospital

Libertyville, Illinois, 60048

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

Loyola University Medical Center

Maywood, Illinois, 60153

United States

Edward Hospital/Cancer Center

Naperville, Illinois, 60540

United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Advocate High Tech Medical Park

Palos Heights, Illinois, 60463

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Valley Radiation Oncology

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Reid Health

Richmond, Indiana, 47374

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, 50023

United States

Saint Anthony Regional Hospital

Carroll, Iowa, 51401

United States

Saint Luke's Hospital

Cedar Rapids, Iowa, 52402

United States

Mercy Hospital

Cedar Rapids, Iowa, 52403

United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, 52403

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, 50314

United States

Iowa Lutheran Hospital

Des Moines, Iowa, 50316

United States

Methodist West Hospital

West Des Moines, Iowa, 50266-7700

United States

University of Kansas Cancer Center

Kansas City, Kansas, 66160

United States

Olathe Health Cancer Center

Olathe, Kansas, 66061

United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, 66210

United States

Salina Regional Health Center

Salina, Kansas, 67401

United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, 66606

United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, 70002

United States

East Jefferson General Hospital

Metairie, Louisiana, 70006

United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006

United States

Tulane University School of Medicine

New Orleans, Louisiana, 70112

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, 04412

United States

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Henry Ford Hospital

Detroit, Michigan, 48202

United States

McLaren Cancer Institute-Flint

Flint, Michigan, 48532

United States

Singh and Arora Hematology Oncology PC

Flint, Michigan, 48532

United States

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910

United States

Mid-Michigan Physicians-Lansing

Lansing, Michigan, 48912

United States

McLaren Cancer Institute-Macomb

Mount Clemens, Michigan, 48043

United States

McLaren Cancer Institute-Owosso

Owosso, Michigan, 48867

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Unity Hospital

Fridley, Minnesota, 55432

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422

United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, 56303

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Ridgeview Medical Center

Waconia, Minnesota, 55387

United States

Rice Memorial Hospital

Willmar, Minnesota, 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

University of Kansas Cancer Center - North

Kansas City, Missouri, 64154

United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064

United States

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, 64116

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Cancer Partners of Nebraska - Pine Lake

Lincoln, Nebraska, 68516

United States

Cancer Partners of Nebraska

Lincoln, Nebraska, 68516

United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, 89052

United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

United States

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106

United States

GenesisCare USA - Las Vegas

Las Vegas, Nevada, 89109

United States

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, 89119

United States

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128

United States

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, 89128

United States

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, 89144

United States

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144

United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148

United States

GenesisCare USA - Fort Apache

Las Vegas, Nevada, 89148

United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89148

United States

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169

United States

Renown Regional Medical Center

Reno, Nevada, 89502

United States

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301

United States

Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103

United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

United States

Cooper Hospital University Medical Center

Camden, New Jersey, 08103

United States

Saint Barnabas Medical Center

Livingston, New Jersey, 07039

United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Rutgers New Jersey Medical School

Newark, New Jersey, 07101

United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876

United States

MD Anderson Cancer Center at Cooper-Voorhees

Voorhees, New Jersey, 08043

United States

Sands Cancer Center

Canandaigua, New York, 14424

United States

Memorial Sloan Kettering Commack

Commack, New York, 11725

United States

Northwell Health Physicians Partners Radiation Medicine at Queens

Forest Hills, New York, 11375

United States

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

United States

Garnet Health Medical Center

Middletown, New York, 10940

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Queens Cancer Center

Rego Park, New York, 11374

United States

Wilmot Cancer Institute Radiation Oncology at Greece

Rochester, New York, 14606

United States

Highland Hospital

Rochester, New York, 14620

United States

University of Rochester

Rochester, New York, 14642

United States

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553

United States

Duke Cancer Institute Cary

Cary, North Carolina, 27518

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Duke Raleigh Hospital

Raleigh, North Carolina, 27609

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

Cleveland Clinic Akron General

Akron, Ohio, 44307

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Cleveland Clinic Cancer Center/Fairview Hospital

Cleveland, Ohio, 44111

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Armes Family Cancer Center

Findlay, Ohio, 45840

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Cleveland Clinic Cancer Center Mansfield

Mansfield, Ohio, 44906

United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, 44124

United States

North Coast Cancer Care

Sandusky, Ohio, 44870

United States

Cleveland Clinic Cancer Center Strongsville

Strongsville, Ohio, 44136

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

Cleveland Clinic Wooster Family Health and Surgery Center

Wooster, Ohio, 44691

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030

United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009

United States

Crozer-Keystone Regional Cancer Center at Broomall

Broomall, Pennsylvania, 19008

United States

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317

United States

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121

United States

Crozer Regional Cancer Center at Brinton Lake

Glen Mills, Pennsylvania, 19342

United States

UPMC Cancer Centers - Arnold Palmer Pavilion

Greensburg, Pennsylvania, 15601

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850

United States

IRMC Cancer Center

Indiana, Pennsylvania, 15701

United States

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901

United States

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, 15132

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

UPMC Cancer Center - Monroeville

Monroeville, Pennsylvania, 15146

United States

UPMC Hillman Cancer Center in Coraopolis

Moon, Pennsylvania, 15108

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

UPMC-Saint Clair Hospital Cancer Center

Pittsburgh, Pennsylvania, 15243

United States

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346

United States

UPMC Uniontown Hospital Radiation Oncology

Uniontown, Pennsylvania, 15401

United States

Crozer-Chester Medical Center

Upland, Pennsylvania, 19013

United States

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, 15301

United States

Chester County Hospital

West Chester, Pennsylvania, 19380

United States

Reading Hospital

West Reading, Pennsylvania, 19611

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390

United States

Tarrant County Hospital District/JPS Health Network

Fort Worth, Texas, 76104

United States

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104

United States

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080

United States

Audie L Murphy VA Hospital

San Antonio, Texas, 78229

United States

VCU Massey Cancer Center at Hanover Medical Park

Mechanicsville, Virginia, 23116

United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, 23114

United States

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, 23230

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686

United States

West Virginia University Charleston Division

Charleston, West Virginia, 25304

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, 54911

United States

Aurora Cancer Care-Southern Lakes VLCC

Burlington, Wisconsin, 53105

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Aurora Health Care Germantown Health Center

Germantown, Wisconsin, 53022

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Cancer Care-Kenosha South

Kenosha, Wisconsin, 53142

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Aurora Cancer Care-Milwaukee

Milwaukee, Wisconsin, 53209

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aurora Cancer Care-Racine

Racine, Wisconsin, 53406

United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Diagnostic and Treatment Center

Weston, Wisconsin, 54476

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494

United States

Collaborators and Investigators

Sponsor: NRG Oncology

Ronald C Chen, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-05

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2020-03-05

Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

Prostate Adenocarcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage IIA Prostate Cancer AJCC v8
Stage IIB Prostate Cancer AJCC v8
Stage IIC Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
Stage IIIC Prostate Cancer AJCC v8
Stage IVA Prostate Cancer AJCC v8