RECRUITING

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

Conditions

Biochemically Recurrent Prostate Carcinoma Metastatic Prostate Carcinoma Prostate Adenocarcinoma Stage IVB 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 tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.

Official Title

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Quick Facts

Study Start:2020-10-08

Study Completion:2032-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04423211

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
* 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)	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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)

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Neha Vapiwala

PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Study Locations (Sites)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508

United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508

United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508

United States

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

United States

Anchorage Oncology Centre

Anchorage, Alaska, 99508

United States

Katmai Oncology Group

Anchorage, Alaska, 99508

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, 93420

United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505

United States

Mercy Cancer Center - Carmichael

Carmichael, California, 95608

United States

Mercy San Juan Medical Center

Carmichael, California, 95608

United States

City of Hope Corona

Corona, California, 92879

United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, 95758

United States

UC San Diego Moores Cancer Center

La Jolla, California, 92093

United States

City of Hope Antelope Valley

Lancaster, California, 93534

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

United States

Mercy Cancer Center

Merced, California, 95340

United States

Mercy Cancer Center - Rocklin

Rocklin, California, 95765

United States

Mercy Cancer Center - Sacramento

Sacramento, California, 95816

United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, 93401

United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, 93444

United States

City of Hope South Pasadena

South Pasadena, California, 91030

United States

City of Hope Upland

Upland, California, 91786

United States

Woodland Memorial Hospital

Woodland, California, 95695

United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907

United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907

United States

Saint Francis Cancer Center

Colorado Springs, Colorado, 80923

United States

Porter Adventist Hospital

Denver, Colorado, 80210

United States

Saint Anthony Hospital

Lakewood, Colorado, 80228

United States

Littleton Adventist Hospital

Littleton, Colorado, 80122

United States

Longmont United Hospital

Longmont, Colorado, 80501

United States

Parker Adventist Hospital

Parker, Colorado, 80138

United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, 81004

United States

Sibley Memorial Hospital

Washington, District of Columbia, 20016

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83686

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Alton Memorial Hospital

Alton, Illinois, 62002

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

United States

SIH Cancer Institute

Carterville, Illinois, 62918

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Saint Mary's Hospital

Centralia, Illinois, 62801

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

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

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

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

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

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

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

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

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

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, 61114

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Memorial Medical Center

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, 60555

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530

United States

Saint Joseph Hospital

Lexington, Kentucky, 40504

United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, 40504

United States

Saint Joseph Hospital East

Lexington, Kentucky, 40509

United States

Jewish Hospital

Louisville, Kentucky, 40202

United States

MaineHealth Coastal Cancer Treatment Center

Bath, Maine, 04530

United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford

Biddeford, Maine, 04005

United States

Maine Medical Center-Bramhall Campus

Portland, Maine, 04102

United States

MaineHealth Cancer Care Center of York County

Sanford, Maine, 04073

United States

MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford

Sanford, Maine, 04073

United States

Maine Medical Center- Scarborough Campus

Scarborough, Maine, 04074

United States

Maine Medical Partners - South Portland

South Portland, Maine, 04106

United States

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287

United States

Suburban Hospital

Bethesda, Maryland, 20814

United States

UM Baltimore Washington Medical Center/Tate Cancer Center

Glen Burnie, Maryland, 21061

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

Health Partners Inc

Minneapolis, Minnesota, 55454

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

Baptist Cancer Center-Grenada

Grenada, Mississippi, 38901

United States

University of Mississippi Medical Center

Jackson, Mississippi, 39216

United States

Baptist Memorial Hospital and Cancer Center-Union County

New Albany, Mississippi, 38652

United States

Baptist Memorial Hospital and Cancer Center-Oxford

Oxford, Mississippi, 38655

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Southeast Cancer Center

Cape Girardeau, Missouri, 63703

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

United States

Freeman Health System

Joplin, Missouri, 64804

United States

Mercy Hospital Joplin

Joplin, Missouri, 64804

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

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

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Great Falls Clinic

Great Falls, Montana, 59405

United States

Kalispell Regional Medical Center

Kalispell, Montana, 59901

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802

United States

Community Medical Center

Missoula, Montana, 59804

United States

CHI Health Good Samaritan

Kearney, Nebraska, 68847

United States

Alegent Health Immanuel Medical Center

Omaha, Nebraska, 68122

United States

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124

United States

Alegent Health Lakeside Hospital

Omaha, Nebraska, 68130

United States

Creighton University Medical Center

Omaha, Nebraska, 68131

United States

Cooper Hospital University Medical Center

Camden, New Jersey, 08103

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903

United States

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, 08876

United States

Community Medical Center

Toms River, New Jersey, 08755

United States

MD Anderson Cancer Center at Cooper-Voorhees

Voorhees, New Jersey, 08043

United States

Northwell Health Imbert Cancer Center

Bay Shore, New York, 11706

United States

Montefiore Medical Center-Einstein Campus

Bronx, New York, 10461

United States

Montefiore Medical Center-Weiler Hospital

Bronx, New York, 10461

United States

Montefiore Medical Center - Moses Campus

Bronx, New York, 10467

United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

United States

Mount Sinai Union Square

New York, New York, 10003

United States

Mount Sinai Chelsea

New York, New York, 10011

United States

Mount Sinai West

New York, New York, 10019

United States

Lenox Hill Hospital

New York, New York, 10021

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Manhattan Eye Ear and Throat Hospital

New York, New York, 10065

United States

Phelps Memorial Hospital Center

Sleepy Hollow, New York, 10591

United States

Stony Brook University Medical Center

Stony Brook, New York, 11794

United States

Westchester Medical Center

Valhalla, New York, 10595

United States

ECU Health Oncology Kenansville

Kenansville, North Carolina, 28349

United States

ECU Health Oncology Kinston

Kinston, North Carolina, 28501

United States

ECU Health Oncology Richlands

Richlands, North Carolina, 28574

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, 45220

United States

Bethesda North Hospital

Cincinnati, Ohio, 45242

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

United States

Saint Charles Health System

Bend, Oregon, 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

United States

Bay Area Hospital

Coos Bay, Oregon, 97420

United States

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, 97210

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062

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

Delaware County Memorial Hospital

Drexel Hill, Pennsylvania, 19026

United States

Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

East Norriton, Pennsylvania, 19401

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121

United States

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, 18925

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

UPMC-Johnstown/John P. Murtha Regional Cancer Center

Johnstown, Pennsylvania, 15901

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 Cancer Center-Natrona Heights

Natrona Heights, Pennsylvania, 15065

United States

UPMC Hillman Cancer Center - New Castle

New Castle, Pennsylvania, 16105

United States

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104

United States

University of Pennsylvania/Abramson Cancer Center

Philadelphia, Pennsylvania, 19104

United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

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 Cancer Center-Uniontown

Uniontown, Pennsylvania, 15401

United States

UPMC Uniontown Hospital Radiation Oncology

Uniontown, Pennsylvania, 15401

United States

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, 15301

United States

UPMC Susquehanna

Williamsport, Pennsylvania, 17701

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

UT Southwestern Simmons Cancer Center - RedBird

Dallas, Texas, 75237

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

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

University of Virginia Cancer Center

Charlottesville, Virginia, 22908

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225

United States

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Providence Regional Cancer Partnership

Everett, Washington, 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington, 98632

United States

Skagit Regional Health Cancer Care Center

Mount Vernon, Washington, 98274

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107

United States

FHCC South Lake Union

Seattle, Washington, 98109

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

FHCC at Northwest Hospital

Seattle, Washington, 98133

United States

University of Washington Medical Center - Montlake

Seattle, Washington, 98195

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284

United States

Saint Michael Cancer Center

Silverdale, Washington, 98383

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664

United States

Legacy Cancer Institute Medical Oncology and Day Treatment

Vancouver, Washington, 98684

United States

Legacy Salmon Creek Hospital

Vancouver, Washington, 98686

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

University of Wisconsin Carbone Cancer Center - Johnson Creek

Johnson Creek, Wisconsin, 53038

United States

William S Middleton VA Medical Center

Madison, Wisconsin, 53705

United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Ascension Saint Mary's Hospital

Rhinelander, Wisconsin, 54501

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Ascension Saint Michael's Hospital

Stevens Point, Wisconsin, 54481

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494

United States

Welch Cancer Center

Sheridan, Wyoming, 82801

United States

Collaborators and Investigators

Sponsor: ECOG-ACRIN Cancer Research Group

Neha Vapiwala, PRINCIPAL_INVESTIGATOR, ECOG-ACRIN Cancer Research Group

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 Date2020-10-08

Study Completion Date2032-12-31

Study Record Updates

Study Start Date2020-10-08

Study Completion Date2032-12-31

Terms related to this study

Additional Relevant MeSH Terms

Biochemically Recurrent Prostate Carcinoma
Metastatic Prostate Carcinoma
Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8