Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer
Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8
About this trial
This is an interventional treatment trial for Prostate Adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted
- Any T-stage is eligible (American Joint Committee on Cancer [AJCC] 8th edition [ed])
- Appropriate stage for study entry based on fluciclovine F-18 positron emission tomography (PET) scan (FACBC, Axumin) within 90 days prior to registration that is negative for distant metastatic (M1a, M1b, M1c) disease; Note that though every effort should be made to obtain a fluciclovine F-18 PET (FACBC, Axumin) scan; however, if the patient has already had a recent F-18 PSMA PET scan or gallium Ga 68-labeled PSMA-11 (Ga-68 PSMA) PET scan or C-11 or F-18 choline PET scan within 90 days prior to registration (to include scan report) then repeat molecular imaging with a fluciclovine F-18 PET (FACBC, Axumin) scan will not be required.
- Pathologically node positive disease with nodal involvement only in the pelvis in the prostatectomy specimen (including external iliacs, internal iliacs, and/or obturator nodes); peri-rectal nodes can also be considered regional lymphadenopathy and are allowed
- History/physical examination within 90 days prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 90 days prior to registration
- Detectable PSA after radical prostatectomy. Detectable PSA is defined as serum PSA > 0 ng/mL at least 30 days after prostatectomy and within 180 days of registration and before start of GnRH agonist/antagonist
- Patients who have already started on post-prostatectomy GnRH agonist/antagonist for =< 180 days prior to registration are eligible (Note: patients who started on an oral antiandrogen are eligible if started =< 180 days and stopped prior to registration)
- Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors (within 90 days prior to registration)
- Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors (within 90 days prior to registration)
- Serum potassium >= 3.5 mmol/L within 90 days prior to registration
- Creatinine clearance (CrCl) >= 30 mL/min estimated by Cockcroft-Gault (please use actual weight for calculation unless greater than 30% above ideal body weight then use the adjusted body weight) (within 90 days prior to registration)
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject is eligible) (within 90 days prior to registration)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) or alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (within 90 days prior to registration)
- Serum albumin >= 3.0 g/dL (within 90 days prior to registration)
- Discontinue or substitute concomitant medications known to lower the seizure threshold at least 30 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 30 days prior to registration. 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 within 30 days prior to registration, if indicated. Note: HBV viral testing is not required for eligibility for this protocol
- 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 30 days prior to registration
- 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) who has no evidence of disease for < 3 years must contact the principal investigator, Ronald Chen, Doctor of Medicine (MD)
- The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
- Definitive radiologic evidence of metastatic disease (M1a, M1b or M1c) on molecular imaging (e.g. fluciclovine F-18 PET, F-18 PSMA, PSMA, F-18 choline 11)
- Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowed (completed > 3 years prior to registration)
- Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
- Androgen deprivation therapy (ADT) prior to radical prostatectomy
- Prior treatment with androgen receptor signaling inhibitor (including but not exclusive to a growing list of: abiraterone acetate, enzalutamide, apalutamide, darolutamide), unless started =< 180 days and stopped prior to registration, which is allowed
- Current use of 5-alpha reductase inhibitor. NOTE: if the alpha reductase inhibitor is stopped prior to randomization the patient is eligible
History of any of the following:
- Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year prior to registration, brain arteriovenous malformation, Schwannoma, meningioma, or other benign central nervous system [CNS] or meningeal disease which may require treatment with surgery or radiation therapy)
- Severe or unstable angina, myocardial infarction, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 12 months prior to registration
- New York Heart Association functional classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification.)
- History of any condition that in the opinion of the investigator, would preclude participation in this study
Current evidence of any of the following:
- Known gastrointestinal disorder affecting absorption of oral medications
- Active uncontrolled infection
- Presence of uncontrolled hypertension (persistent systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg). Subjects with a history of hypertension are allowed, provided that BP is controlled to within these limits by anti-hypertensive treatment
- Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
- Baseline moderate and severe hepatic impairment (Child-Pugh Class B & C)
- Inability to swallow oral pills
- Any current condition that in the opinion of the investigator, would preclude participation in this study
- Patients must not plan to participate in any other therapeutic clinical trials while receiving treatment on this study
- Patients with inflammatory bowel disease
Sites / Locations
- University of Arkansas for Medical SciencesRecruiting
- Kaiser Permanente-AnaheimRecruiting
- Kaiser Permanente-Baldwin ParkRecruiting
- Kaiser Permanente-BellflowerRecruiting
- Kaiser Permanente-FontanaRecruiting
- Marin General HospitalRecruiting
- Kaiser Permanente - Harbor CityRecruiting
- Kaiser Permanente-IrvineRecruiting
- Tibor Rubin VA Medical CenterRecruiting
- Kaiser Permanente Los Angeles Medical CenterRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Kaiser Permanente West Los AngelesRecruiting
- UCLA / Jonsson Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-OntarioRecruiting
- Kaiser Permanente - Panorama CityRecruiting
- Kaiser Permanente-RiversideRecruiting
- University of California Davis Comprehensive Cancer CenterRecruiting
- Kaiser Permanente-San Diego ZionRecruiting
- UCSF Medical Center-Mount ZionRecruiting
- UCSF Medical Center-ParnassusRecruiting
- UCSF Medical Center-Mission BayRecruiting
- Kaiser Permanente-San MarcosRecruiting
- Ridley-Tree Cancer Center
- Kaiser Permanente-Woodland HillsRecruiting
- Beebe South Coastal Health CampusRecruiting
- Helen F Graham Cancer CenterRecruiting
- Medical Oncology Hematology Consultants PARecruiting
- Christiana Care Health System-Christiana HospitalRecruiting
- Beebe Health CampusRecruiting
- George Washington University Medical CenterRecruiting
- Grady Health SystemRecruiting
- Emory Proton Therapy CenterRecruiting
- Emory University Hospital MidtownRecruiting
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's HospitalRecruiting
- Alton Memorial HospitalRecruiting
- Rush - Copley Medical CenterRecruiting
- Advocate Good Shepherd HospitalRecruiting
- 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
- AMG Crystal Lake - OncologyRecruiting
- Carle at The RiverfrontRecruiting
- Decatur Memorial HospitalRecruiting
- Northwestern Medicine Cancer Center Kishwaukee
- Illinois CancerCare-DixonRecruiting
- Advocate Good Samaritan HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Advocate Sherman HospitalRecruiting
- Elmhurst Memorial HospitalRecruiting
- Illinois CancerCare-EurekaRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Western Illinois Cancer Treatment CenterRecruiting
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- Advocate South Suburban HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- AMG Libertyville - OncologyRecruiting
- Condell Memorial HospitalRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Loyola University Medical CenterRecruiting
- Edward Hospital/Cancer CenterRecruiting
- UC Comprehensive Cancer Center at Silver CrossRecruiting
- University of Chicago Medicine-Orland ParkRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Advocate Lutheran General HospitalRecruiting
- Illinois CancerCare-PekinRecruiting
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment CenterRecruiting
- Illinois CancerCare-PeoriaRecruiting
- OSF Saint Francis Radiation Oncology at Peoria Cancer CenterRecruiting
- Methodist Medical Center of IllinoisRecruiting
- OSF Saint Francis Medical CenterRecruiting
- Illinois CancerCare-PeruRecruiting
- Valley Radiation OncologyRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Northwestern Medicine Cancer Center Warrenville
- Illinois CancerCare - WashingtonRecruiting
- Reid HealthRecruiting
- McFarland Clinic - AmesRecruiting
- Saint Luke's HospitalRecruiting
- Mercy HospitalRecruiting
- Oncology Associates at Mercy Medical CenterRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Mercy Medical Center - Des MoinesRecruiting
- Iowa Lutheran HospitalRecruiting
- Methodist West HospitalRecruiting
- University of Kansas Cancer CenterRecruiting
- Olathe Health 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
- East Jefferson General HospitalRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- Tulane University Health Sciences CenterRecruiting
- Ochsner Medical Center JeffersonRecruiting
- Lafayette Family Cancer Center-EMMCRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Brigham and Women's HospitalRecruiting
- Dana-Farber Cancer InstituteRecruiting
- Henry Ford HospitalRecruiting
- McLaren Cancer Institute-FlintRecruiting
- Singh and Arora Hematology Oncology PCRecruiting
- Karmanos Cancer Institute at McLaren Greater LansingRecruiting
- Mid-Michigan Physicians-LansingRecruiting
- McLaren Cancer Institute-MacombRecruiting
- McLaren Cancer Institute-OwossoRecruiting
- Minnesota Oncology - BurnsvilleRecruiting
- Mercy HospitalRecruiting
- Fairview Southdale HospitalRecruiting
- Unity HospitalRecruiting
- Fairview Clinics and Surgery Center Maple GroveRecruiting
- Minnesota Oncology Hematology PA-MaplewoodRecruiting
- Saint John's Hospital - HealtheastRecruiting
- Abbott-Northwestern HospitalRecruiting
- Hennepin County Medical CenterRecruiting
- Monticello Cancer CenterRecruiting
- North Memorial Medical Health CenterRecruiting
- Coborn Cancer Center at Saint Cloud HospitalRecruiting
- Park Nicollet Clinic - Saint Louis ParkRecruiting
- Regions HospitalRecruiting
- United HospitalRecruiting
- Saint Francis Regional Medical CenterRecruiting
- Lakeview HospitalRecruiting
- Ridgeview Medical CenterRecruiting
- Rice Memorial HospitalRecruiting
- Minnesota Oncology Hematology PA-WoodburyRecruiting
- Saint Louis Cancer and Breast Institute-Ballwin
- Saint Francis Medical 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
- Washington University School of MedicineRecruiting
- Siteman Cancer Center-South CountyRecruiting
- Siteman Cancer Center at Christian HospitalRecruiting
- Mercy Hospital Saint LouisRecruiting
- Siteman Cancer Center at Saint Peters HospitalRecruiting
- Billings Clinic Cancer CenterRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Cancer Partners of Nebraska - Pine LakeRecruiting
- Southeast Nebraska Cancer Center - 68th Street PlaceRecruiting
- Comprehensive Cancer Centers of Nevada - HendersonRecruiting
- OptumCare Cancer Care at Seven HillsRecruiting
- OptumCare Cancer Care at CharlestonRecruiting
- Radiation Oncology Centers of Nevada CentralRecruiting
- GenesisCare USA - Las VegasRecruiting
- Radiation Oncology Centers of Nevada SoutheastRecruiting
- Comprehensive Cancer Centers of Nevada - NorthwestRecruiting
- OptumCare Cancer Care at MountainViewRecruiting
- Comprehensive Cancer Centers of Nevada - Town CenterRecruiting
- Comprehensive Cancer Centers of Nevada-SummerlinRecruiting
- Comprehensive Cancer Centers of NevadaRecruiting
- GenesisCare USA - Fort ApacheRecruiting
- OptumCare Cancer Care at Fort ApacheRecruiting
- Comprehensive Cancer Centers of Nevada - Central ValleyRecruiting
- Renown Regional Medical CenterRecruiting
- New Hampshire Oncology Hematology PA-ConcordRecruiting
- Solinsky Center for Cancer CareRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Cooper Hospital University Medical CenterRecruiting
- Saint Barnabas Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Robert Wood Johnson University Hospital SomersetRecruiting
- MD Anderson Cancer Center at Cooper-VoorheesRecruiting
- Sands Cancer CenterRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Northwell Health Physicians Partners Radiation Medicine at QueensRecruiting
- Queens Medical Associates PCRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Garnet Health Medical CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Wilmot Cancer Institute Radiation Oncology at GreeceRecruiting
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Duke Cancer Institute CaryRecruiting
- Duke University Medical CenterRecruiting
- Duke Raleigh HospitalRecruiting
- Wake Forest University Health SciencesRecruiting
- Cleveland Clinic Akron GeneralRecruiting
- University of Cincinnati Cancer Center-UC Medical CenterRecruiting
- Cleveland Clinic Cancer Center/Fairview HospitalRecruiting
- Cleveland Clinic FoundationRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Armes Family Cancer CenterRecruiting
- Cleveland Clinic Cancer Center MansfieldRecruiting
- Hillcrest Hospital Cancer CenterRecruiting
- North Coast Cancer CareRecruiting
- Cleveland Clinic Cancer Center StrongsvilleRecruiting
- 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 Center
- Legacy Good Samaritan Hospital and Medical Center
- 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
- Delaware County Memorial HospitalRecruiting
- UPMC Hillman Cancer Center ErieRecruiting
- UPMC Cancer Center at UPMC HorizonRecruiting
- 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
- UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
- UPMC Cancer Center at UPMC McKeesport
- UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
- UPMC Cancer Center - MonroevilleRecruiting
- UPMC Hillman Cancer Center in CoraopolisRecruiting
- UPMC-Magee Womens HospitalRecruiting
- UPMC-Saint MargaretRecruiting
- UPMC-Shadyside HospitalRecruiting
- UPMC-Passavant HospitalRecruiting
- UPMC-Saint Clair Hospital Cancer CenterRecruiting
- UPMC Cancer Center at UPMC NorthwestRecruiting
- UPMC Uniontown Hospital Radiation OncologyRecruiting
- Crozer-Chester Medical Center
- UPMC Washington Hospital Radiation OncologyRecruiting
- Chester County HospitalRecruiting
- Reading HospitalRecruiting
- UPMC MemorialRecruiting
- UT Southwestern/Simmons Cancer Center-DallasRecruiting
- UT Southwestern/Simmons Cancer Center-Fort WorthRecruiting
- UT Southwestern Clinical Center at Richardson/PlanoRecruiting
- Audie L Murphy VA HospitalRecruiting
- VCU Massey Cancer Center at Hanover Medical ParkRecruiting
- VCU Massey Cancer Center at Stony PointRecruiting
- Virginia Commonwealth University/Massey Cancer CenterRecruiting
- Legacy Salmon Creek Hospital
- West Virginia University Charleston DivisionRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- ThedaCare Regional Cancer CenterRecruiting
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Marshfield Medical Center-EC Cancer CenterRecruiting
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Bellin Memorial HospitalRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Marshfield Medical Center-MarshfieldRecruiting
- Froedtert Menomonee Falls HospitalRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of WisconsinRecruiting
- Aurora Sinai Medical CenterRecruiting
- Marshfield Clinic-Minocqua CenterRecruiting
- Cancer Center of Western WisconsinRecruiting
- Drexel Town Square Health CenterRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Marshfield Medical Center-Rice LakeRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Ascension Saint Michael's HospitalRecruiting
- Marshfield Medical Center-River Region at Stevens PointRecruiting
- Aurora Medical Center in SummitRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Froedtert West Bend Hospital/Kraemer Cancer CenterRecruiting
- Diagnostic and Treatment CenterRecruiting
- Marshfield Medical Center - WestonRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (hormone therapy, radiation therapy)
Arm II (hormone therapy, radiation therapy, apalutamide)
Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity.
Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity.