A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Castration-Resistant Prostatic Cancer

In brief

The purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (AAP) compared to AAP and placebo.

Key facts

Study ID

NCT03748641

Run by

Janssen Research & Development, LLC

People needed

765

Starts

2019-01-25

Expected to finish

2027-02-27

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• HRR gene alteration (as identified by the sponsor's required assays) as follows:
• Cohort 1: positive for HRR gene alteration
• Cohort 2: not positive for DRD (that is, HRR gene alteration)
• Cohort 3: eligible by HRR status
• Metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI)
• Metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (<=) 50 nanogram per deciliter (ng/dL) on a gonadotropin releasing hormone analog (GnRHa) or bilateral orchiectomy
• Able to continue GnRHa during the study if not surgically castrate
• Score of <= 3 on the brief pain inventory-short form (BPI-SF) question number 3 (worst pain in last 24 hours)

You may not qualify if…

• Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor
• Systemic therapy (that is, novel second-generation AR-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone [AAP] prior to randomization) in the metastatic castration-resistant prostate cancer (mCRPC) setting; or AAP outside of the mCRPC setting
• Symptomatic brain metastases
• History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
• Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) <= 2 years prior to randomization, or malignancy that currently requires active systemic therapy

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Urological Associates of Southern Arizona, P.C. — Tucson, Arizona, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• Kaiser Permanente — Riverside, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• University of California San Francisco — San Francisco, California, United States
• Sansum Clinic Pharm — Santa Barbara, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Colorado Clinical Research — Lakewood, Colorado, United States
• VA Connecticut Healthcare — West Haven, Connecticut, United States
• Bay Pines VA Healthcare System — Bay Pines, Florida, United States
• Advanced Urology Institute — Daytona Beach, Florida, United States
• University of Florida Health Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic - Division Of Hematology/oncology — Jacksonville, Florida, United States
• Veterans Affairs Medical Ctr — Hines, Illinois, United States
• Fort Wayne Medical Oncology and Hematology — Fort Wayne, Indiana, United States
• First Urology — Jeffersonville, Indiana, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Norton Healthcare — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Rcca Md, Llc — Bethesda, Maryland, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Massachusetts General — Boston, Massachusetts, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• Urology Centers Of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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