Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
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
3 other identifiers
interventional
586
2 countries
350
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2020
Longer than P75 for phase_3
350 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2019
CompletedFirst Posted
Study publicly available on registry
October 22, 2019
CompletedStudy Start
First participant enrolled
April 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
June 25, 2026
June 1, 2026
6.5 years
October 18, 2019
June 22, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Metastasis-free survival (MFS)
Kaplan-Meier curves will be generated and metastasis-free survival compared between the two treatment groups by a logrank test, stratified by prostate specific antigen (PSA) level after prostatectomy (never detectable or rising). Cox regression modeling to assess and adjust for the effects of PSA stratum and other baseline covariates will also be performed. The proportional hazards assumption will be tested using Schoenfeld residuals and graphical methods. Martingale residual plots will be examined to determine the best functional form for incorporating covariates into the model. A competing risks analysis will also be performed with time to distant metastasis or death from prostate cancer as the event of interest and death from other causes as the competing risk. Cumulative incidence curves will be generated along with Fine-Gray's test. Patients alive and metastasis free will be censored as of the time of the last negative examination.
From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years
Secondary Outcomes (7)
Quality of life (QOL) between the two treatment arms
Up to 3 years post treatment
Overall survival (OS)
From randomization until date of death or censored at last date known alive, assessed up to 7.5 years
Biochemical progression-free survival (bPFS)
From randomization until biochemical recurrence or death from prostate cancer, assessed up to 7.5 years
Time to local-regional progression
Up to 7.5 years
Time to castrate resistance
Up to 7.5 years
- +2 more secondary outcomes
Other Outcomes (6)
MFS by Decipher genomic score
Up to 7.5 years
OS by Decipher genomic score
Up to 7.5 years
PAM50-based classification of prostate cancer
Up to 7.5 years
- +3 more other outcomes
Study Arms (2)
Arm I (hormone therapy, radiation therapy)
ACTIVE COMPARATORPatients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.
Arm II (hormone therapy, radiation therapy, apalutamide)
EXPERIMENTALPatients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90 of each cycle. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.
Interventions
Undergo MRI
Given PO
Undergo blood sample collection
Undergo bone scan
Undergo CT
Receive hormone therapy
Undergo PET
Ancillary studies
Ancillary studies
Undergo pelvis and prostate bed radiation therapy
Eligibility Criteria
You may qualify if:
- 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)
- +8 more criteria
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NRG Oncologylead
- National Cancer Institute (NCI)collaborator
Study Sites (350)
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
Woodland Memorial Hospital
Woodland, California, 95695, United States
Kaiser Permanente-Woodland Hills
Woodland Hills, California, 91367, 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 D.C., District of Columbia, 20037, United States
UM Sylvester Comprehensive Cancer Center at Aventura
Aventura, Florida, 33180, United States
UM Sylvester Comprehensive Cancer Center at Coral Gables
Coral Gables, Florida, 33146, United States
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Deerfield Beach, Florida, 33442, United States
UM Sylvester Comprehensive Cancer Center at Doral
Doral, Florida, 33166, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
UM Sylvester Comprehensive Cancer Center at Kendall
Miami, Florida, 33176, United States
UM Sylvester Comprehensive Cancer Center at Plantation
Plantation, Florida, 33324, 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 Decatur Hospital
Decatur, Georgia, 30033, 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 Outpatient Center - Aurora
Aurora, Illinois, 60506, 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 MD Anderson Cancer 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
Ingalls Memorial Hospital
Harvey, Illinois, 60426, 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
Carle BroMenn Medical Center
Normal, Illinois, 61761, United States
Carle Cancer Institute Normal
Normal, Illinois, 61761, United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois, 62269, United States
Northwestern Medicine Oak Brook
Oak Brook, Illinois, 60523, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699, United States
Northwestern Medicine Orland Park
Orland Park, Illinois, 60462, 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
Memorial Hospital East
Shiloh, Illinois, 62269, 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
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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
UI Health Care Mission Cancer and Blood - Laurel Clinic
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
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
The University of Kansas Cancer Center - Olathe
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
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana, 70805, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, 70808, 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
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, 48114, United States
Trinity Health Medical Center - Canton
Canton, Michigan, 48188, United States
Chelsea Hospital
Chelsea, Michigan, 48118, 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
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, 48043, United States
McLaren Cancer Institute-Owosso
Owosso, Michigan, 48867, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341, 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
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, 63011, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
MU Health - University Hospital/Ellis Fischel Cancer Center
Columbia, Missouri, 65212, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
Freeman Health System
Joplin, Missouri, 64804, United States
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri, 64116, 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
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, 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
Lincoln, Nebraska, 68516, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074, 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
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
Oncology Las Vegas - Tenaya
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
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89183, 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 Township, 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
Wilmot Cancer Institute at Webster
Webster, New York, 14580, United States
Duke Cancer Center Cary
Cary, North Carolina, 27518, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Duke Cancer Center Raleigh
Raleigh, North Carolina, 27609, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, 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 Township, 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 - Mitchell
Mitchell, South Dakota, 57301, United States
Avera Cancer Institute at Pierre
Pierre, South Dakota, 57501, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, 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
VCU Massey Comprehensive 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
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, 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
Marshfield Medical Center - Weston
Weston, Wisconsin, 54476, United States
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin, 54494, United States
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
Related Publications (1)
Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.
PMID: 38421243DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald C Chen
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2019
First Posted
October 22, 2019
Study Start
April 16, 2020
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.