Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
Metastatic Malignant Neoplasm in the Bone, Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8
About this trial
This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Bone
Eligibility Criteria
Inclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION
- Pathologically proven diagnosis of adenocarcinoma of prostate cancer within 180 days prior to registration
High-risk disease defined as having at least one or more of the following:
- PSA > 20 ng/mL prior to starting ADT
- cT3a-T4 by digital exam or imaging (American Joint Committee on Cancer [AJCC] 8th edition [Ed.])
- Gleason score of 8-10
- Node positive by conventional imaging with a short axis of at least 1.0 cm
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 120 days prior to registration;
Bone imaging within 120 days prior to registration;
- Note: To be eligible, patient must have no definitive evidence of bone metastases (M0) on bone scan or sodium fluoride (NaF) PET within 120 days prior to registration (negative NaF PET/CT or negative Axumin or choline PET or negative fluciclovine, choline or prostate-specific membrane antigen (PSMA) PET within 120 days prior to registration is an acceptable substitute if they have been performed). Patients who have bone metastases established only fluciclovine, choline, or PSMA PET but not definitive on bone scan or NaF PET will still be eligible
- CT or MRI of the pelvis within 120 days prior to registration (negative fluciclovine, choline, or PSMA PET within 120 days prior to registration is an acceptable substitute). As with bone staging, nodal staging for trial purposes will be based off of conventional imaging findings only
- Patients with confirmed N1 metastases on conventional imaging (CT/MRI) as defined by >= 10 mm on short axis are eligible but will be automatically assigned to the intensification study. Patients who are positive by fluciclovine, choline, or PSMA PET (i.e. N1), but whose nodes do not meet traditional size criteria for positivity (i.e. they measure =< 10 mm on either the CT or MRI portion of the PET or on a dedicated CT or MRI) will not be considered N1 for the trial and will not automatically be assigned to the intensification study
- Age >= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
- Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
- Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 120 days prior to registration)
Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault equation (within 120 days prior to registration)
- For Black patients whose renal function is not considered adequate by Cockcroft-Gault formula, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) may be used for calculating creatinine clearance for trial eligibility
- Either a CrCl >= 30 ml/min or calculated glomerular filtration rate (GFR) >= 30 will make a patient eligible
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (within 120 days prior to registration)
- 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
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 120 days prior to registration)
- Serum albumin >= 3.0 g/dL (within 120 days prior to registration)
- The patient must agree to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agree to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial and have a CD4 count >= 200 cells/microliter within 60 days prior to registration. Note: HIV testing is not required for eligibility for this protocol. Of note, for patients with HIV in the intensification trial randomized to apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with apalutamide
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable after or on suppressive therapy within 60 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Any patient with a cancer (other than keratinocyte carcinoma or carcinoma in situ or low-grade non-muscle invasive bladder cancer) who has been disease-free for less than 3 years must contact the principal investigator
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
- PRIOR TO STEP 2 RANDOMIZATION
- Confirmation of Decipher score
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load within 60 days prior. Note: Apalutamide may interfere with HCV drugs. Patients on HCV medications should alert their infectious diseases physician if they get randomized to apalutamide due to the possibility that apalutamide can affect the bioavailability of some HCV medications. HCV viral testing is not required for eligibility for this protocol
- For patients entering the Intensification Cohort ONLY: Patients must discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 days prior to Step 2 randomization
Exclusion Criteria:
- PRIOR TO STEP 1 REGISTRATION:
- Definitive radiologic evidence of metastatic disease outside of the pelvic nodes (M1a, M1b or M1c) on conventional imaging (i.e. bone scan, CT scan, MRI)
- Prior systemic chemotherapy within =< 3 years prior to registration; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration
- Prior radical prostatectomy
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- 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 disorder
- Current severe or unstable angina
- 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
Evidence of any of the following at registration:
- Active uncontrolled infection requiring IV antibiotics
- Baseline severe hepatic impairment (Child Pugh Class C)
- Inability to swallow oral pills
- Any current condition that in the opinion of the investigator, would preclude participation in this study
- Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation (both luteinizing hormone-releasing hormone [LHRH] agonist and oral anti-androgen) is =< 60 days prior to registration; Please note: baseline PSA must be obtained prior to the start of any ADT
- PRIOR TO STEP 2 RANDOMIZATION:
- Evidence of known gastrointestinal disorder affecting absorption of oral medications at registration
- For patients entering the Intensification Cohort ONLY: 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
Sites / Locations
- Fairbanks Memorial HospitalRecruiting
- Arizona Breast Cancer Specialists-Gilbert
- Arizona Center for Cancer Care-Peoria
- Arizona Breast Cancer Specialists-ScottsdaleRecruiting
- University of Arkansas for Medical SciencesRecruiting
- City of Hope Comprehensive Cancer CenterRecruiting
- Kaiser Permanente DublinRecruiting
- Kaiser Permanente-FremontRecruiting
- Washington HospitalRecruiting
- Kaiser Permanente-FresnoRecruiting
- Marin General HospitalRecruiting
- City of Hope at Irvine LennarRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- City of Hope Antelope ValleyRecruiting
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Cedars Sinai Medical CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Kaiser Permanente-OaklandRecruiting
- Saint Joseph Hospital - OrangeRecruiting
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Stanford Cancer Institute Palo AltoRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- Kaiser Permanente-San FranciscoRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Stanford Cancer Center South BayRecruiting
- Kaiser Permanente San LeandroRecruiting
- UCSF Cancer Center - San MateoRecruiting
- Kaiser Permanente Medical Center - Santa ClaraRecruiting
- Kaiser Permanente-Santa RosaRecruiting
- City of Hope South PasadenaRecruiting
- Kaiser Permanente-South San FranciscoRecruiting
- Cedars-Sinai Cancer - TarzanaRecruiting
- City of Hope South BayRecruiting
- Torrance Memorial Physician Network - Cancer CareRecruiting
- Torrance Memorial Medical CenterRecruiting
- Gene Upshaw Memorial Tahoe Forest Cancer CenterRecruiting
- City of Hope UplandRecruiting
- Kaiser Permanente-VallejoRecruiting
- Kaiser Permanente-Walnut CreekRecruiting
- UCHealth University of Colorado HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- UCHealth Memorial Hospital CentralRecruiting
- Memorial Hospital NorthRecruiting
- Shaw Cancer CenterRecruiting
- Poudre Valley HospitalRecruiting
- Cancer Care and Hematology-Fort CollinsRecruiting
- North Colorado Medical CenterRecruiting
- UCHealth Greeley HospitalRecruiting
- UCHealth Highlands Ranch HospitalRecruiting
- Medical Center of the RockiesRecruiting
- McKee Medical CenterRecruiting
- Hartford HealthCare - Saint Vincent's Medical CenterRecruiting
- Smilow Cancer Hospital-Derby Care CenterRecruiting
- Smilow Cancer Hospital Care Center-FairfieldRecruiting
- Smilow Cancer Hospital Care Center at GreenwichRecruiting
- Smilow Cancer Hospital Care Center - GuilfordRecruiting
- Hartford HospitalRecruiting
- Smilow Cancer Hospital Care Center at Saint FrancisRecruiting
- Yale UniversityRecruiting
- Yale-New Haven Hospital North Haven Medical CenterRecruiting
- Smilow Cancer Hospital-Orange Care CenterRecruiting
- Smilow Cancer Hospital Care Center at Long RidgeRecruiting
- Smilow Cancer Hospital Care Center-TrumbullRecruiting
- Smilow Cancer Hospital Care Center - WaterfordRecruiting
- Bayhealth Hospital Kent CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- GenesisCare USA - Lakewood Ranch
- Miami Cancer InstituteRecruiting
- GenesisCare USA - Plantation
- Tampa General HospitalRecruiting
- Grady Health SystemRecruiting
- Emory Proton Therapy CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer CenterRecruiting
- Advocate Illinois Masonic Medical CenterRecruiting
- Carle at The RiverfrontRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Crossroads Cancer CenterRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Edward Hospital/Cancer CenterRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- SwedishAmerican Regional Cancer Center/ACTRecruiting
- Memorial Hospital EastRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Saint Luke's HospitalRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- Salina Regional Health CenterRecruiting
- University of Kansas Health System Saint Francis CampusRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- East Jefferson General HospitalRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- Tulane University Health Sciences Center
- MaineHealth Coastal Cancer Treatment CenterRecruiting
- Maine Medical Center-Bramhall CampusRecruiting
- Penobscot Bay Medical CenterRecruiting
- MaineHealth Cancer Care Center of York CountyRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Maryland Proton Treatment CenterRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- University of Maryland Shore Medical Center at EastonRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Brigham and Women's HospitalRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Dana-Farber/Brigham and Women's Cancer Center at Milford RegionalRecruiting
- Dana-Farber/Brigham and Women's Cancer Center at South ShoreRecruiting
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- McLaren Cancer Institute-Bay CityRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- University of Michigan - Brighton Center for Specialty CareRecruiting
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- GenesisCare USA - Clarkston
- McLaren Cancer Institute-ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton TownshipRecruiting
- Beaumont Hospital - DearbornRecruiting
- Henry Ford Medical Center-Fairlane
- Wayne State University/Karmanos Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- GenesisCare USA - Farmington Hills
- Weisberg Cancer Treatment CenterRecruiting
- McLaren Cancer Institute-FlintRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Sparrow HospitalRecruiting
- McLaren Cancer Institute-Lapeer RegionRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- GenesisCare USA - Macomb
- GenesisCare USA - Madison Heights
- McLaren Cancer Institute-MacombRecruiting
- Henry Ford Medical Center-Columbus
- McLaren-Port HuronRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Henry Ford Macomb Health Center - Shelby Township
- Munson Medical CenterRecruiting
- William Beaumont Hospital - TroyRecruiting
- GenesisCare USA - Troy
- Henry Ford West Bloomfield HospitalRecruiting
- University of Michigan Health - WestRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Mayo Clinic Health System in Albert LeaRecruiting
- Mercy HospitalRecruiting
- Miller-Dwan HospitalRecruiting
- Unity HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Monticello Cancer CenterRecruiting
- Mayo Clinic in RochesterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- University of Mississippi Medical CenterRecruiting
- Saint Francis Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- Freeman Health SystemRecruiting
- University of Kansas Cancer Center - NorthRecruiting
- University of Kansas Cancer Center - Lee's SummitRecruiting
- University of Kansas Cancer Center at North Kansas City HospitalRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Mercy Hospital SpringfieldRecruiting
- Billings Clinic Cancer CenterRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Nebraska Medicine-BellevueRecruiting
- Nebraska Medicine-Village PointeRecruiting
- University of Nebraska Medical CenterRecruiting
- New Hampshire Oncology Hematology PA-ConcordRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Solinsky Center for Cancer CareRecruiting
- Cooper Hospital University Medical CenterRecruiting
- AtlantiCare Surgery CenterRecruiting
- The Cancer Institute of New Jersey HamiltonRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- The Valley Hospital-Luckow PavilionRecruiting
- Valley HospitalRecruiting
- Community Medical CenterRecruiting
- MD Anderson Cancer Center at Cooper-VoorheesRecruiting
- Lovelace Medical Center-Saint Joseph SquareRecruiting
- University of New Mexico Cancer CenterRecruiting
- Lovelace Radiation OncologyRecruiting
- Presbyterian Kaseman Hospital
- Presbyterian Rust Medical Center/Jorgensen Cancer CenterRecruiting
- Northwell Health Imbert Cancer CenterRecruiting
- New York-Presbyterian/Brooklyn Methodist HospitalRecruiting
- Roswell Park Cancer InstituteRecruiting
- Sands Cancer Center
- Noyes Memorial Hospital/Myers Cancer Center
- The New York Hospital Medical Center of QueensRecruiting
- Northwell Health Physicians Partners Radiation Medicine at QueensRecruiting
- Queens Medical Associates PCRecruiting
- Glens Falls HospitalRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Lenox Hill HospitalRecruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- NYP/Weill Cornell Medical CenterRecruiting
- Highland Hospital
- University of RochesterRecruiting
- Phelps Memorial Hospital CenterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Westchester Medical CenterRecruiting
- Duke Cancer Institute Cary
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Atrium Health University City/LCI-UniversityRecruiting
- Levine Cancer Institute-BallantyneRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- Durham VA Medical CenterRecruiting
- Duke University Medical CenterRecruiting
- Novant Health Cancer Institute - HuntersvilleRecruiting
- Novant Health Cancer Institute - MatthewsRecruiting
- Atrium Health Union/LCI-UnionRecruiting
- Novant Health Cancer Institute - MooresvilleRecruiting
- UNC Rex HealthcareRecruiting
- Duke Raleigh Hospital
- UNC Rex Cancer Center of WakefieldRecruiting
- Novant Cancer Institute Radiation Oncology - SupplyRecruiting
- Novant Health Cancer Institute Radiation Oncology - WilmingtonRecruiting
- Novant Health New Hanover Regional Medical CenterRecruiting
- Novant Health Forsyth Medical CenterRecruiting
- Wake Forest University Health SciencesRecruiting
- Altru Cancer CenterRecruiting
- Summa Health System - Akron CampusRecruiting
- Cleveland Clinic Akron GeneralRecruiting
- Summa Health System - Barberton CampusRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Summa Health Medina Medical CenterRecruiting
- ProMedica Flower HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Legacy Mount Hood Medical CenterRecruiting
- Legacy Good Samaritan Hospital and Medical CenterRecruiting
- Legacy Meridian Park HospitalRecruiting
- UPMC AltoonaRecruiting
- UPMC-Heritage Valley Health System BeaverRecruiting
- Crozer-Keystone Regional Cancer Center at BroomallRecruiting
- Carlisle Regional Cancer CenterRecruiting
- Christiana Care Health System-Concord Health CenterRecruiting
- Chambersburg HospitalRecruiting
- Geisinger Medical CenterRecruiting
- Delaware County Memorial HospitalRecruiting
- Ephrata Cancer CenterRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- Saint Vincent HospitalRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- Adams Cancer CenterRecruiting
- Crozer Regional Cancer Center at Brinton LakeRecruiting
- UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
- UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- IRMC Cancer CenterRecruiting
- Jefferson HospitalRecruiting
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- Sechler Family Cancer CenterRecruiting
- Geisinger Medical Oncology-LewisburgRecruiting
- UPMC Cancer Center at UPMC McKeesport
- Yolanda G Barco Oncology InstituteRecruiting
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- Forbes HospitalRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- Thomas Jefferson University HospitalRecruiting
- Allegheny General HospitalRecruiting
- UPMC-Magee Womens HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- West Penn HospitalRecruiting
- University of Pittsburgh Cancer Institute (UPCI)Recruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- Geisinger Cancer Services-PottsvilleRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Cancer Center-UniontownRecruiting
- UPMC Uniontown Hospital Radiation OncologyRecruiting
- UPMC Cancer Center-WashingtonRecruiting
- UPMC Washington Hospital Radiation OncologyRecruiting
- Chester County HospitalRecruiting
- Reading HospitalRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Divine Providence HospitalRecruiting
- Asplundh Cancer PavilionRecruiting
- WellSpan Health-York Cancer CenterRecruiting
- UPMC MemorialRecruiting
- Rhode Island HospitalRecruiting
- Smilow Cancer Hospital Care Center - WesterlyRecruiting
- Saint Joseph's/Candler - Bluffton CampusRecruiting
- Medical University of South CarolinaRecruiting
- MUSC Health Florence Medical Center
- Saint Francis HospitalRecruiting
- Saint Francis Cancer CenterRecruiting
- Self Regional HealthcareRecruiting
- Gibbs Cancer Center-PelhamRecruiting
- Carolina Regional Cancer Center
- Spartanburg Medical CenterRecruiting
- Thompson Cancer Survival CenterRecruiting
- Thompson Oncology Group-MaryvilleRecruiting
- Thompson Oncology Group-Oak RidgeRecruiting
- Houston Methodist San Jacinto HospitalRecruiting
- MD Anderson in The Woodlands
- Houston Methodist HospitalRecruiting
- M D Anderson Cancer Center
- Methodist Willowbrook HospitalRecruiting
- MD Anderson West Houston
- Houston Methodist West HospitalRecruiting
- Houston Methodist Saint John HospitalRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- MD Anderson in Sugar Land
- Houston Methodist The Woodlands HospitalRecruiting
- American Fork Hospital / Huntsman Intermountain Cancer CenterRecruiting
- Farmington Health CenterRecruiting
- Logan Regional HospitalRecruiting
- Intermountain Medical CenterRecruiting
- McKay-Dee Hospital CenterRecruiting
- Utah Valley Regional Medical CenterRecruiting
- Riverton HospitalRecruiting
- Saint George Regional Medical CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Utah Cancer Specialists-Salt Lake CityRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- LDS HospitalRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- Inova Alexandria HospitalRecruiting
- Inova Schar Cancer InstituteRecruiting
- Inova Fair Oaks HospitalRecruiting
- Bon Secours Saint Francis Medical CenterRecruiting
- Bon Secours Cancer Institute at Reynolds CrossingRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Virginia Mason Medical CenterRecruiting
- Legacy Cancer Institute Medical Oncology and Day TreatmentRecruiting
- Legacy Salmon Creek HospitalRecruiting
- Wheeling Hospital/Schiffler Cancer CenterRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- ThedaCare Regional Cancer CenterRecruiting
- Ascension Saint Elizabeth HospitalRecruiting
- Northwest Wisconsin Cancer CenterRecruiting
- Ascension Southeast Wisconsin Hospital - Elmbrook CampusRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Ascension Calumet HospitalRecruiting
- Ascension Saint Francis - Reiman Cancer CenterRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Mayo Clinic Health System-Franciscan HealthcareRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Ascension Columbia Saint Mary's Hospital OzaukeeRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Ascension Columbia Saint Mary's Hospital - MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- Zablocki Veterans Administration Medical CenterRecruiting
- Drexel Town Square Health CenterRecruiting
- Ascension Mercy HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Ascension All Saints HospitalRecruiting
- Aurora Cancer Care-RacineRecruiting
- Saint Vincent Hospital Cancer Center at SheboyganRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Saint Vincent Hospital Cancer Center at Sturgeon BayRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Ascension Medical Group Southeast Wisconsin - Mayfair RoadRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
- Ottawa Hospital and Cancer Center-General CampusRecruiting
- University Health Network-Princess Margaret HospitalRecruiting
- The Research Institute of the McGill University Health Centre (MUHC)
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Active Comparator
Experimental
Arm I (de-intensification study)
Arm II (de-intensification study)
Arm III (intensification study)
Arm IV (intensification study)
Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 24 months in the absence of disease progression or unacceptable toxicity.
Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin and bicalutamide or flutamide) for 12 months in the absence of disease progression or unacceptable toxicity.
Patients undergo RT over 2-11 weeks and receive ADT as in Arm I.
Patients undergo RT over 2-11 weeks and receive ADT (consisting of either leuprolide, goserelin, triptorelin, degarelix, buserelin or histrelin) for 24 months in the absence of disease progression or unacceptable toxicity. Patients also receive apalutamide PO QD. Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.