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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

Trial Status: Active

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Abiraterone acetate may help fight prostate cancer by lowering the amount of testosterone made by the body. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding abiraterone acetate and apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

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 Na F 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 Na F 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
  • 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
  • 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 (didanosine [DDI] is not permitted) 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 abiraterone acetate and apalutamide, highly active antiretroviral therapy (HAART) may need to be adjusted to medications that do not interact with abiraterone acetate and 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
  • For patients entering the Intensification Cohort ONLY: Serum potassium >= 3.5 mmol/L 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
  • Didanosine (DDI) antiretroviral therapy is not permitted
  • 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 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
  • 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 and testosterone 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: Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
  • 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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-826-4673
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 916-734-3089

Delaware

Dover
Bayhealth Hospital Kent Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-744-6755
Newark
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450

Georgia

Atlanta
Emory Proton Therapy Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-251-2854
Emory Saint Joseph's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-851-7115
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-778-1868
Emory University Hospital Midtown
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Contact: Site Public Contact
Phone: 888-946-7447
Grady Health System
Status: ACTIVE
Contact: Site Public Contact
Phone: 404-489-9164

Illinois

Chicago
University of Illinois
Status: ACTIVE
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Decatur Memorial Hospital
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Contact: Site Public Contact
Phone: 217-876-4740
Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-788-3528

Iowa

Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-442-3324

Michigan

Brownstown
Henry Ford Cancer Institute-Downriver
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Clarkston
GenesisCare USA - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Clinton Township
Henry Ford Macomb Hospital-Clinton Township
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Contact: Site Public Contact
Phone: 313-916-3721
Dearborn
Henry Ford Medical Center-Fairlane
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Detroit
Henry Ford Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Farmington Hills
GenesisCare USA - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Macomb
GenesisCare USA - Macomb
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Madison Heights
GenesisCare USA - Madison Heights
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
Novi
Henry Ford Medical Center-Columbus
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721
Shelby Township
Henry Ford Macomb Health Center - Shelby Township
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-1784
Troy
21st Century Oncology MHP - Troy
Status: ACTIVE
Contact: Site Public Contact
Phone: 941-833-5700
West Bloomfield
Henry Ford West Bloomfield Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 313-916-3721

Missouri

Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Louis
Siteman Cancer Center at Christian Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Siteman Cancer Center-South County
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Washington University School of Medicine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-600-3606

Montana

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 406-969-6060

New Jersey

Paramus
The Valley Hospital-Luckow Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792
Ridgewood
Valley Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 201-634-5792

New York

Canandiaqua
Sands Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-396-6161
Rochester
Highland Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-341-8113
University of Rochester
Status: ACTIVE
Contact: Site Public Contact
Phone: 585-275-5830
Stony Brook
Stony Brook University Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-862-2215

North Carolina

Wilmington
NHRMC Radiation Oncology - 16th Street
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-251-1839
New Hanover Regional Medical Center / Zimmer Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-342-3000

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-293-5066

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 405-271-8777

Oregon

Gresham
Legacy Mount Hood Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150
Portland
Legacy Good Samaritan Hospital and Medical Center
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Contact: Site Public Contact
Phone: 800-220-4937
Tualatin
Legacy Meridian Park Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-1742

Pennsylvania

Altoona
UPMC Altoona
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Beaver
UPMC-Heritage Valley Health System Beaver
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-773-7616
Carlisle
Carlisle Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Chadds Ford
Christiana Care Health System-Concord Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Erie
UPMC Hillman Cancer Center Erie
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-389-5208
Farrell
UPMC Cancer Center at UPMC Horizon
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Greensburg
UPMC Cancer Centers - Arnold Palmer Pavilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-838-1900
Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-724-6765
Johnstown
UPMC-Johnstown / John P. Murtha Regional Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-534-4724
McKeesport
UPMC Cancer Center at UPMC McKeesport
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-8073
Mechanicsburg
UPMC Pinnacle West Shore
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Monroeville
UPMC Cancer Center - Monroeville
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-339-5294
Moon Township
UPMC-Coraopolis / Heritage Valley Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-604-2020
Pittsburgh
UPMC-Magee Womens Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-647-2811
UPMC-Passavant Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-367-6454
UPMC-Saint Clair Hospital Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-502-3920
UPMC-Saint Margaret
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-784-4900
UPMC-Shadyside Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 412-621-2334
Seneca
UPMC Cancer Center at UPMC Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 814-676-7900
Uniontown
UPMC Uniontown Hospital Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-437-2503
Washington
UPMC Washington Hospital Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 724-223-3788
York
UPMC Memorial
Status: ACTIVE
Contact: Site Public Contact
Phone: 717-724-6760

South Carolina

Greenville
Saint Francis Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-603-6213
Greenwood
Self Regional Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-725-4771

Tennessee

Knoxville
Thompson Cancer Survival Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 865-331-1812

Washington

Vancouver
Legacy Cancer Institute Medical Oncology and Day Treatment
Status: ACTIVE
Contact: Site Public Contact
Legacy Salmon Creek Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-413-2150

West Virginia

Wheeling
Wheeling Hospital / Schiffler Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 304-243-6442

Wisconsin

Milwaukee
Zablocki Veterans Administration Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-469-6614

PRIMARY OBJECTIVES:

I. To determine whether men with National Comprehensive Cancer Network (NCCN) high risk prostate cancer who are in the lower 2/3 of Decipher genomic risk (=< 0.85) can be treated with 12 months androgen deprivation therapy (ADT) plus radiation therapy (RT) instead of 24 months ADT+RT and experience non-inferior metastasis-free survival. (De-intensification study)

II. To determine whether men with NCCN high risk prostate cancer who are in the upper 1/3 of Decipher genomic risk (> 0.85) or have node-positive disease by conventional imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) will have a superior metastasis-free survival (MFS) through treatment intensification with apalutamide and abiraterone acetate with prednisone added to the standard of RT plus 24 month ADT. (Intensification study)

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) between the standard of care (RT plus 24 months of ADT) and either the de intensification (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

II. To compare time to prostate specific antigen (PSA) failure or start of salvage treatment between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

III. To compare PSA failure-free survival with non-castrate testosterone and no additional therapies between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

IV. To compare MFS judged based on either standard or molecular imaging between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

V. To compare prostate cancer-specific mortality between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

VI. To compare testosterone levels at the time of PSA failure and metastases between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

VII. To compare time to testosterone recovery (defined as a T > 200) between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

VIII. To compare adverse events, both clinician-reported using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0 and patient-reported using patient reported outcome (PRO)-CTCAE items, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

CORRELATIVE STUDIES OBJECTIVE:

I. To compare extra-prostatic uptake on the positron emission tomography (PET)-CT between the standard of care (RT plus 24 months of ADT) and intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (Intensification study)

EXPLORATORY OBJECTIVES:

I. To compare changes in cardio-metabolic markers, including body mass index, and waist circumference, between the standard of care (RT plus 24 months of ADT) and either the de-intensification arm (RT plus 12 months of ADT) or intensification arm (RT plus 24 months of ADT plus apalutamide and abiraterone acetate with prednisone). (De-intensification and intensification studies)

II. To determine a machine learning/artificial intelligence algorithm for radiotherapy quality assurance. (De-intensification and Intensification studies)

III. To perform future translational correlative studies using biological and imaging data. (De-intensification and intensification studies)

OUTLINE: Patients are randomized to 1 of 4 arms.

DE-INTENSIFICATION STUDY (DECIPHER SCORE =< 0.85):

ARM I: Patients undergo radiation therapy (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.

ARM II: 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.

INTENSIFICATION STUDY (DECIPHER SCORE > 0.85 OR NODE POSITIVE):

ARM III: 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.

ARM IV: 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, abiraterone acetate and prednisone orally (PO) once daily (QD). Treatment repeats every 90 days for up to 8 cycles (24 months) in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up annually.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
NRG Oncology

Principal Investigator
Paul L. Nguyen

  • Primary ID NRG-GU009
  • Secondary IDs NCI-2020-04705
  • Clinicaltrials.gov ID NCT04513717