Two Studies for Patients With Unfavorable Intermediate 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 Higher Gene Risk Score
Prostate Adenocarcinoma

About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma of the prostate within 270 days prior to registration
Unfavorable intermediate risk prostate cancer, defined as having ALL the following bulleted criteria:
Has at least one intermediate risk factor (IRF):
- PSA 10-20 ng/mL
- Clinical stage T2b-c (digital rectal examination [DRE] and/or imaging) by American Joint Committee on Cancer (AJCC) 8th edition
- Gleason score 7 (Gleason 3+4 or 4+3 [ International Society of Urological Pathology (ISUP) Grade Group 2-3])
Has ONE or more of the following 'unfavorable' intermediate-risk designators:
- > 1 immature reticulocyte fraction (IRF)
- Gleason 4+3=7 (ISUP Grade Group 3)
>= 50% of biopsy cores positive
- Biopsies may include 'sextant' sampling of right/left regions of the prostate, often labeled base, mid-gland and apex. All such 'sextant' biopsy cores should be counted. Men may also undergo 'targeted' sampling of prostate lesions (guided by MRI, ultrasound or other approaches). A targeted lesion that is biopsied more than once and demonstrates cancer (regardless of number of targeted cores involved) should count as a single additional positive core sampled and positive. In cases of uncertainty, count the biopsy sampling as sextant core(s)
- Absence of high-risk features
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 120 days prior to registration;
- Negative bone imaging (M0) within 120 days prior to registration; Note: Tc-99m bone scan or sodium fluoride (NaF) positron emission tomography (PET) are allowed. Equivocal bone scan findings are allowed if plain films X-ray, computed tomography (CT) or magnetic resonance imaging (MRI) are negative for metastasis at the concerned site(s). While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for bone imaging, any suspicious findings must be confirmed and correlated with conventional imaging (Tc-99m bone scan, NaF PET, CT, X-ray, or MRI) to determine eligibility based on the latter modalities (e.g. M0 based on conventional imaging modalities)
- Clinically negative lymph nodes (N0) as established by conventional imaging (pelvic +/- abdominal CT or MR), within 120 days prior to registration. Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are =< 1.0 cm in short axis and/or if biopsy is negative.
Note: While a negative fluciclovine, choline, or prostate specific membrane antigen (PSMA) PET may be counted as acceptable substitute for pelvic imaging, any suspicious findings must be confirmed by conventional imaging (CT, MRI or biopsy). If the findings do not meet pathological criteria based on the latter modalities (e.g. node =< 10 mm in short axis, negative biopsy), the patient will still be eligible
- Age >= 18
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 120 days prior to registration
- Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
- Absolute neutrophil >= 1,000 cells/mm^3 (within 120 days prior to registration)
- Hemoglobin >= 8.0 g/dL, independent of transfusion and/or growth factors (within 120 days prior to registration)
- Platelet count >= 100,000 cells/mm^3 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 African American patients specifically whose renal function is not considered adequate by the formula above, an alternative formula that takes race into account (Chronic Kidney Disease Epidemiology Collaboration CKD-EPI formula) should be used for calculating the related estimated glomerular filtration rate (GFR) with a correction factor for African American race creatinine clearance for trial eligibility, where GFR >= 30 mL/min/1.73m^2 will be considered adequate
- Total bilirubin: 1.5 =< 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. If direct bilirubin is less than or equal to 1.5 x ULN, subject is eligible)
- Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase [SGPT]): =< 2.5 x institutional ULN (within 120 days prior to registration)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial; Note: HIV testing is not required for eligibility for this protocol
For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
For 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
- Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion Criteria:
- Previous radical surgery (prostatectomy) or any form of curative-intent ablation whether focal or whole-gland (e.g., cryosurgery, high intensity focused ultrasound [HIFU], laser thermal ablation, etc.) for prostate cancer
- Definitive clinical or radiologic evidence of metastatic disease (M1)
- Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years. History of or current diagnosis of hematologic malignancy is not allowed
- Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields
- Previous bilateral orchiectomy
- Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., leuprolide, goserelin, buserelin, triptorelin) or LHRH antagonist (e.g. degarelix), anti-androgens (e.g., flutamide, bicalutamide, cyproterone acetate). ADT started prior to study registration is not allowed
- Prior use of 5-alpha-reductase inhibitors is allowed, however, it must be stopped prior to enrollment on the study with at least a 30 day washout period before baseline study PSA measure and registration
- Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration
Severe, active co-morbidity defined as follows:
- 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
- Inability to swallow oral pills
High risk features, which includes any of the following:
- Gleason 8-10 [ISUP Grade Group 4-5]
- PSA > 20
- cT3-4 by digital exam OR gross extra-prostatic extension on imaging [indeterminate MRI evidence will not count and the patient will be eligible]
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- University of Arkansas for Medical SciencesRecruiting
- Sutter Cancer Centers Radiation Oncology Services-AuburnRecruiting
- AIS Cancer Center at San Joaquin Community HospitalRecruiting
- Tower Cancer Research FoundationRecruiting
- City of Hope CoronaRecruiting
- 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
- City of Hope Antelope ValleyRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Cedars Sinai Medical CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Kaiser Permanente-ModestoRecruiting
- Providence Queen of The ValleyRecruiting
- Kaiser Permanente-OaklandRecruiting
- Saint Joseph Hospital - OrangeRecruiting
- Kaiser Permanente-RosevilleRecruiting
- Sutter Cancer Centers Radiation Oncology Services-RosevilleRecruiting
- Kaiser Permanente Downtown CommonsRecruiting
- Kaiser Permanente-South SacramentoRecruiting
- Kaiser Permanente-San FranciscoRecruiting
- Kaiser Permanente-Santa Teresa-San JoseRecruiting
- Kaiser Permanente San LeandroRecruiting
- Ridley-Tree Cancer CenterRecruiting
- 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
- 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
- Beebe South Coastal Health CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Beebe Health CampusRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- GenesisCare USA - Plantation
- Cleveland Clinic-WestonRecruiting
- Grady Health SystemRecruiting
- Emory Proton Therapy CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Piedmont Hospital
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Piedmont Fayette Hospital
- Northeast Georgia Medical Center-GainesvilleRecruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/CandlerRecruiting
- Saint Luke's Cancer Institute - BoiseRecruiting
- Saint Luke's Cancer Institute - FruitlandRecruiting
- Saint Luke's Cancer Institute - MeridianRecruiting
- Saint Luke's Cancer Institute - NampaRecruiting
- Saint Luke's Cancer Institute - Twin FallsRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Northwestern UniversityRecruiting
- Rush University Medical CenterRecruiting
- University of IllinoisRecruiting
- Carle at The RiverfrontRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- 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
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- 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
- University of Kansas Cancer CenterRecruiting
- University of Kansas Cancer Center-Overland ParkRecruiting
- University of Kansas Hospital-Indian Creek CampusRecruiting
- Salina Regional Health CenterRecruiting
- Cotton O'Neil Cancer Center / Stormont Vail HealthRecruiting
- University of Kansas Hospital-Westwood Cancer CenterRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- East Jefferson General HospitalRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- Maine Medical Center-Bramhall CampusRecruiting
- Maine Medical Center- Scarborough CampusRecruiting
- Maine Medical Partners - South PortlandRecruiting
- Anne Arundel Medical Center
- Maryland Proton Treatment CenterRecruiting
- University of Maryland/Greenebaum Cancer CenterRecruiting
- UM Upper Chesapeake Medical CenterRecruiting
- University of Maryland Shore Medical Center at EastonRecruiting
- UM Baltimore Washington Medical Center/Tate Cancer CenterRecruiting
- Beverly HospitalRecruiting
- Lahey Hospital and Medical CenterRecruiting
- Addison Gilbert HospitalRecruiting
- Lahey Medical Center-PeabodyRecruiting
- Winchester HospitalRecruiting
- 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
- Henry Ford Cancer Institute-DownriverRecruiting
- 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
- 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
- McLaren Cancer Institute-Northern MichiganRecruiting
- Saint Joseph Mercy OaklandRecruiting
- McLaren-Port HuronRecruiting
- William Beaumont Hospital-Royal OakRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Ascension Saint Joseph HospitalRecruiting
- 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
- Miller-Dwan HospitalRecruiting
- Saint Luke's Hospital of DuluthRecruiting
- Hennepin County Medical CenterRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- Saint Francis Medical CenterRecruiting
- MU Health - University Hospital/Ellis Fischel Cancer CenterRecruiting
- Siteman Cancer Center at West County HospitalRecruiting
- 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
- SSM Health Saint Louis University HospitalRecruiting
- 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
- Saint James Community Hospital and Cancer Treatment Center
- 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
- Memorial Sloan Kettering Basking RidgeRecruiting
- Cooper Hospital University Medical CenterRecruiting
- AtlantiCare Surgery CenterRecruiting
- Saint Barnabas Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- The Valley Hospital-Luckow PavilionRecruiting
- Robert Wood Johnson University Hospital SomersetRecruiting
- MD Anderson Cancer Center at Cooper-VoorheesRecruiting
- University of New Mexico Cancer CenterRecruiting
- 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
- Memorial Sloan Kettering CommackRecruiting
- Noyes Memorial Hospital/Myers Cancer CenterRecruiting
- Arnot Ogden Medical Center/Falck Cancer CenterRecruiting
- The New York Hospital Medical Center of QueensRecruiting
- Glens Falls HospitalRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Lenox Hill HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Phelps Memorial Hospital CenterRecruiting
- Stony Brook University Medical CenterRecruiting
- State University of New York Upstate Medical UniversityRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Westchester Medical CenterRecruiting
- Mission Hospital
- Durham VA Medical CenterRecruiting
- Novant Cancer Institute Radiation Oncology - SupplyRecruiting
- Novant Health Cancer Institute Radiation Oncology - WilmingtonRecruiting
- Novant Health New Hanover Regional Medical CenterRecruiting
- Sanford Bismarck Medical CenterRecruiting
- Sanford Broadway Medical CenterRecruiting
- Sanford Roger Maris Cancer CenterRecruiting
- Altru Cancer CenterRecruiting
- Summa Health System - Akron CampusRecruiting
- Cleveland Clinic Akron GeneralRecruiting
- UH Seidman Cancer Center at UH Avon Health CenterRecruiting
- Summa Health System - Barberton CampusRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Case Western Reserve UniversityRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- Summa Health Medina Medical CenterRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- University Hospitals Portage Medical CenterRecruiting
- North Coast Cancer CareRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- ProMedica Flower HospitalRecruiting
- South Pointe HospitalRecruiting
- University of Cincinnati Cancer Center-West ChesterRecruiting
- Cleveland Clinic Wooster Family Health and Surgery CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Legacy Mount Hood Medical CenterRecruiting
- Legacy Good Samaritan Hospital and Medical CenterRecruiting
- Providence Portland Medical CenterRecruiting
- Oregon Health and Science UniversityRecruiting
- 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 Hospital
- 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 Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- Forbes HospitalRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- Allegheny Valley HospitalRecruiting
- Thomas Jefferson University HospitalRecruiting
- Jefferson Torresdale HospitalRecruiting
- Allegheny General 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
- Chester County HospitalRecruiting
- Reading HospitalRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Geisinger Wyoming Valley/Henry Cancer CenterRecruiting
- Divine Providence HospitalRecruiting
- WellSpan Health-York Cancer CenterRecruiting
- UPMC MemorialRecruiting
- 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
- Sanford Cancer Center Oncology ClinicRecruiting
- Sanford USD Medical Center - Sioux FallsRecruiting
- Vanderbilt University/Ingram Cancer CenterRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- Brooke Army Medical CenterRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- University of Texas Health Science Center at San AntonioRecruiting
- Farmington Health CenterRecruiting
- University of Utah Sugarhouse Health CenterRecruiting
- Huntsman Cancer Institute/University of UtahRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- Norris Cotton Cancer Center-NorthRecruiting
- 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
- 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
- Bellin Memorial HospitalRecruiting
- Saint Vincent Hospital Cancer Center Green BayRecruiting
- Saint Vincent Hospital Cancer Center at Saint Mary'sRecruiting
- Aurora BayCare Medical CenterRecruiting
- UW Cancer Center Johnson CreekRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- 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
- Marshfield Clinic-Minocqua CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Drexel Town Square Health CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Ascension Mercy HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Ascension All Saints HospitalRecruiting
- Aurora Cancer Care-RacineRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- 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
- UW Cancer Center at ProHealth CareRecruiting
- 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
- Atlantic Health Sciences Corporation-Saint John Regional HospitalRecruiting
- University Health Network-Princess Margaret HospitalRecruiting
- The Research Institute of the McGill University Health Centre (MUHC)Recruiting
- CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)Recruiting
- Centre Hospitalier Universitaire de Sherbrooke-FleurimontRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm I (RT)
Arm II (RT, ADT)
Arm III (RT, ADT)
Arm IV (RT, ADT, darolutamide)
Patients undergo RT using a recognized regimen (2-3 days a week or 5 days a week for 2-11 weeks) in the absence of disease progression or unacceptable toxicity.
Patients undergo RT as Arm I. Patients also receive ADT consisting of leuprolide, goserelin, buserelin, histrelin, triptorelin, degarelix, or relugolix at the discretion of the treating physician, for 6 months in the absence of disease progression or unacceptable toxicity. Patients may also receive bicalutamide or flutamide for 0, 30 or 180 days.
Patients receive treatment as in Arm II.
Patients receive RT and ADT as in Arm II. Patients also receive darolutamide PO BID on days 1-90. Treatment repeats every 90 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.