Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial
A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy With or Without Enhanced Anti-Androgen Therapy With Apalutamide in Recurrent Prostate Cancer (BALANCE*)
3 other identifiers
interventional
324
2 countries
360
Brief Summary
This phase II trial studies how well radiation therapy with or without apalutamide works in treating patients with prostate cancer that has come back (recurrent). Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgen can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may lessen the amount of androgen made by the body. Giving radiation therapy and apalutamide may work better at treating prostate cancer compared to radiation therapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2018
Longer than P75 for phase_2
360 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
December 8, 2017
CompletedFirst Posted
Study publicly available on registry
December 13, 2017
CompletedStudy Start
First participant enrolled
June 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedJanuary 14, 2026
January 1, 2026
6.7 years
December 8, 2017
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Biochemical progression-free survival (bPFS)
bPFS curves will be estimated by the Kaplan-Meier (1958) method and compared between the two treatment arms using a one-sided logrank test at the alpha = 0.12 significance level. In addition, a multivariable Cox regression model will be fit incorporating the three stratification factors used in the randomization (surgical margins, pre-salvage radiation \[SRT\] PSA, and molecular subtype) as covariates to estimate the adjusted hazard ratio (HR) between the two treatment groups. Additional regression models will be fit including other pretreatment characteristics as covariates. The goodness-of-fit of the proportional hazards assumption will be evaluating using graphical methods (Kay, 1977), residual plots, and the global test proposed by Grambsch and Therneau (1994). Missing covariates will be handled using multiple imputation as described in White and Royston (1982).
From randomization to the first occurrence of a rise in PSA, clinical or radiographic local, regional, or distant metastases, or death from any cause, assessed up to 5 years
Secondary Outcomes (14)
Overall survival (OS)
From randomization until death from any cause, assessed up to 5 years
Cancer-specific mortality (CSM)
From the date of randomization to the date of death due to prostate cancer, assessed up to 5 years
Metastasis-free survival (MFS)
From randomization until distant metastasis (clinical and/or radiographic appearance of disseminated disease) or death from any cause, assessed up to 5 years
Distant metastasis
Up to 5 years
Local-regional progression
From randomization to local or regional recurrence ignoring biochemical failure and distant recurrence and censoring for death, assessed up to 5 years
- +9 more secondary outcomes
Study Arms (2)
Arm 1 (radiation therapy, placebo)
ACTIVE COMPARATORPatients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive placebo PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Arm 2 (radiation therapy, apalutamide)
EXPERIMENTALPatients undergo external beam radiation therapy on day 1 for 7-8 weeks. Beginning on day of radiation therapy, patients receive apalutamide PO QD on days 1-30. Treatment repeats every 30 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Undergo external beam radiation therapy
Eligibility Criteria
You may qualify if:
- Pathologically (histologically) proven diagnosis of prostate adenocarcinoma; prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
- Post-prostatectomy patients with a detectable serum PSA (\>= 0.1, but =\< 1.0 ng/mL) at study entry (within 90 days of Step 1 registration) and at least one of the following:
- Gleason score 7-10 (International Society of Urological Pathology \[ISUP\] grade group 2 to 5)
- ISUP grade group:
- Grade group 1 = Gleason score =\< 6,
- Grade group 2 = Gleason score 3 + 4 = 7,
- Grade group 3 = Gleason score 4 + 3 = 7,
- Grade group 4 = Gleason score 8,
- Grade group 5 = Gleason scores 9 and 10
- \>= T3a disease
- Persistent elevation of PSA after prostatectomy measured within 90 days after surgery (PSA never became undetectable) of \> 0.04 but \< 0.2 ng/mL (PSA nadir)
- pN0 or pNx
- History/physical examination within 90 days prior to Step 1 registration
- Karnofsky performance status of 70-100 within 90 days prior to Step 1 registration
- Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on Decipher GRID platform; Note: if Decipher results have already been obtained, in lieu of tissue, results must be submitted to GenomeDx for validation and for GenomeDx to provide the subtyping needed for stratification
- +14 more criteria
You may not qualify if:
- PRIOR TO STEP 1 REGISTRATION:
- Definitive clinical, radiologic, or pathologic evidence of metastatic disease (M1) or lymph node involvement (N1)
- Prior invasive malignancy (except non-melanomatous skin cancer, carcinoma in situ of the male breast, penis, oral cavity, or stage Ta of the bladder, or stage I completely resected melanoma) unless disease free for a minimum of 2 years
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- 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 Step 1 registration)
- History of documented inflammatory bowel disease
- Transmural myocardial infarction within the last 4 months prior to Step 1 registration
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to Step 1 registration
- 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 (e.g., human immunodeficiency virus \[HIV\] or viral hepatitis)
- Uncontrolled hypertension
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- NRG Oncologylead
Study Sites (360)
Arizona Center for Cancer Care - Gilbert
Gilbert, Arizona, 85297, United States
Arizona Center for Cancer Care-Peoria
Peoria, Arizona, 85381, United States
Arizona Center for Cancer Care - Scottsdale
Scottsdale, Arizona, 85258, United States
Arizona Center for Cancer Care-Surprise
Surprise, Arizona, 85374, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, 94704, United States
Marin General Hospital
Greenbrae, California, 94904, United States
Los Angeles General Medical Center
Los Angeles, California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville, California, 95661, United States
Sutter Medical Center Sacramento
Sacramento, California, 95816, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, 94589, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care and Hematology-Fort Collins
Fort Collins, Colorado, 80528, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
UCHealth Greeley Hospital
Greeley, Colorado, 80631, United States
Medical Center of the Rockies
Loveland, Colorado, 80538, United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, 06904, United States
Helen F Graham Cancer Center
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
AdventHealth Altamonte
Altamonte Springs, Florida, 32701, United States
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida, 33905, United States
AdventHealth Kissimmee
Kissimmee, Florida, 34744, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
AdventHealth East Orlando
Orlando, Florida, 32822, United States
Cleveland Clinic-Weston
Weston, Florida, 33331, United States
AdventHealth Winter Park
Winter Park, Florida, 32792, United States
Grady Health System
Atlanta, Georgia, 30303, 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
Northside Hospital
Atlanta, Georgia, 30342, United States
Augusta University Medical Center
Augusta, Georgia, 30912, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho, 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, 83687, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, 83301, United States
Rush MD Anderson Cancer Center
Chicago, Illinois, 60612, United States
University of Illinois
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Edward Hines Jr VA Hospital
Hines, Illinois, 60141, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, 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
Parkview Hospital Randallia
Fort Wayne, Indiana, 46805, United States
Parkview Regional Medical Center
Fort Wayne, Indiana, 46845, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Reid Health
Richmond, Indiana, 47374, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, 50325, United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325, United States
Greater Regional Medical Center
Creston, Iowa, 50801, 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
Mercy Medical Center-West Lakes
West Des Moines, Iowa, 50266, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, 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 Hospital-Westwood Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
East Jefferson General Hospital
Metairie, Louisiana, 70006, United States
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006, United States
MaineHealth Coastal Cancer Treatment Center
Bath, Maine, 04530, United States
MaineHealth Waldo Hospital
Belfast, Maine, 04915, United States
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, 04005, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
MaineHealth Stephens Hospital
Norway, Maine, 04268, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, 04102, United States
Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, 04073, United States
MaineHealth Cancer Care Center of York County
Sanford, Maine, 04073, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, 04074, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, 04106, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
Central Maryland Radiation Oncology in Howard County
Columbia, Maryland, 21044, United States
UM Baltimore Washington Medical Center/Tate Cancer Center
Glen Burnie, Maryland, 21061, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106, United States
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, 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
Michigan Healthcare Professionals Clarkston
Clarkston, Michigan, 48346, United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan, 48038, United States
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Michigan State University
East Lansing, Michigan, 48823, United States
Michigan Healthcare Professionals Farmington
Farmington Hills, Michigan, 48334, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503, United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan, 49503, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912, United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan, 49120, United States
Corewell Health Reed City Hospital
Reed City, Michigan, 49677, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, 48073, United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Corewell Health Beaumont Troy Hospital
Troy, Michigan, 48085, United States
Michigan Healthcare Professionals Troy
Troy, Michigan, 48098, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322, United States
University of Michigan Health - West
Wyoming, Michigan, 49519, United States
Mayo Clinic Health System in Albert Lea
Albert Lea, Minnesota, 56007, United States
Fairview Ridges Hospital
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
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001, 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
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417, 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
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, 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
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703, United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141, United States
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, 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
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, 65401, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Siteman Cancer Center-South County
St Louis, Missouri, 63129, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, 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
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada, 89052, United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada, 89052, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074, United States
Oncology Las Vegas - Henderson
Henderson, Nevada, 89074, United States
Desert West Surgery
Las Vegas, Nevada, 89102, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, 89103, United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada, 89106, United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada, 89109, United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada, 89113, United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada, 89119, United States
Cancer Therapy and Integrative Medicine
Las Vegas, Nevada, 89121, United States
Ann M Wierman MD LTD
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128, United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
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-Summerlin
Las Vegas, Nevada, 89144, United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144, United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada, 89148-2405, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148, United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada, 89149, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169, United States
University Cancer Center
Las Vegas, Nevada, 89169, United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada, 89048, United States
Radiation Oncology Associates
Reno, Nevada, 89509, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756, United States
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey, 08080, United States
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106, United States
New Mexico Oncology Hematology Consultants
Albuquerque, New Mexico, 87109, United States
New York-Presbyterian/Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Sands Cancer Center
Canandaigua, New York, 14424, United States
Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, 10016, 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
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
James J Peters VA Medical Center
The Bronx, New York, 10468, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Novant Cancer Institute Radiation Oncology - Supply
Supply, North Carolina, 28462, United States
Novant Health Cancer Institute Radiation Oncology - Wilmington
Wilmington, North Carolina, 28401, United States
Novant Health New Hanover Regional Medical Center
Wilmington, North Carolina, 28401, United States
Summa Health System - Akron Campus
Akron, Ohio, 44304, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio, 44122, United States
Indu and Raj Soin Medical Center
Beavercreek, Ohio, 45431, United States
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio, 45459, United States
Miami Valley Hospital South
Centerville, Ohio, 45459, United States
Geauga Hospital
Chardon, Ohio, 44024, United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, 45219, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Case Western Reserve University
Cleveland, Ohio, 44106, 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
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Dayton Physician LLC - Englewood
Dayton, Ohio, 45415, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Armes Family Cancer Center
Findlay, Ohio, 45840, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Orion Cancer Care
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Dayton Physicians LLC-Atrium
Franklin, Ohio, 45005, United States
Dayton Physicians LLC-Wayne
Greenville, Ohio, 45331, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Greater Dayton Cancer Center
Kettering, Ohio, 45409, United States
First Dayton Cancer Care
Kettering, Ohio, 45420, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Cleveland Clinic Cancer Center Mansfield
Mansfield, Ohio, 44906, United States
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124, United States
UH Seidman Cancer Center at Lake Health Mentor Campus
Mentor, Ohio, 44060, United States
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio, 44130, United States
University Hospitals Parma Medical Center
Parma, Ohio, 44129, United States
University Hospitals Portage Medical Center
Ravenna, Ohio, 44266, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio, 44870, United States
Springfield Regional Cancer Center
Springfield, Ohio, 45504, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136, United States
Dayton Physicians LLC - Troy
Troy, Ohio, 45373, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, 45069, United States
UHHS-Westlake Medical Center
Westlake, Ohio, 44145, 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
Cancer Treatment Centers of America
Tulsa, Oklahoma, 74133, 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
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317, United States
Northeast Radiation Oncology Center
Dunmore, Pennsylvania, 18512, United States
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, 16121, 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 Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, 15132, United States
UPMC Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146, United States
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, 15108, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114, 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
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, 16346, United States
UPMC Uniontown Hospital Radiation Oncology
Uniontown, Pennsylvania, 15401, United States
UPMC Washington Hospital Radiation Oncology
Washington, Pennsylvania, 15301, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania, 19090, United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316, United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Self Regional Healthcare
Greenwood, South Carolina, 29646, United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650, United States
The Radiation Oncology Center-Hilton Head/Bluffton
Hilton Head Island, South Carolina, 29926, United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
The West Clinic - Wolf River
Germantown, Tennessee, 38138, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, 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
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Farmington Health Center
Farmington, Utah, 84025, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Riverton Hospital
Riverton, Utah, 84065, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Saint George Regional Medical Center
St. George, Utah, 84770, United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, 05819, United States
Naval Medical Center - Portsmouth
Portsmouth, Virginia, 23708-2197, United States
Hunter Holmes McGuire Veterans Administration Medical Center
Richmond, Virginia, 23249, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Legacy Salmon Creek Hospital
Vancouver, Washington, 98686, United States
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, 99362, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden Clark Medical Center
Parkersburg, West Virginia, 26101, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, 54701, United States
Aurora Cancer Care-Grafton
Grafton, Wisconsin, 53024, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, 53142, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, 54449, United States
Froedtert Menomonee Falls Hospital
Menomonee Falls, Wisconsin, 53051, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Zablocki Veterans Administration Medical Center
Milwaukee, Wisconsin, 53295, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, 54548, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan, Wisconsin, 53081, 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
Vince Lombardi Cancer Clinic-Two Rivers
Two Rivers, Wisconsin, 54241, 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
Arthur J E Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 5G2, Canada
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4, Canada
The Research Institute of the McGill University Health Centre (MUHC)
Montreal, Quebec, H3H 2R9, Canada
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
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
Related Publications (2)
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 III: Salvage Therapy After Radiotherapy or Focal Therapy, Pelvic Nodal Recurrence and Oligometastasis, and Future Directions. J Urol. 2024 Apr;211(4):526-532. doi: 10.1097/JU.0000000000003890. Epub 2024 Feb 29.
PMID: 38421252DERIVEDMorgan 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
Felix Y Feng
NRG Oncology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2017
First Posted
December 13, 2017
Study Start
June 20, 2018
Primary Completion
March 10, 2025
Study Completion
March 1, 2026
Last Updated
January 14, 2026
Record last verified: 2026-01