ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT03748641

Public ClinicalTrials.gov record NCT03748641. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 9, 2026, 9:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects With Metastatic Prostate Cancer

Study identification

NCT ID
NCT03748641
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Janssen Research & Development, LLC
Industry
Enrollment
765 participants

Conditions and interventions

Interventions

  • Abiraterone Acetate Drug
  • New Formulation of Niraparib and Abiraterone Acetate (AA) Drug
  • Niraparib Drug
  • Placebo Drug
  • Prednisone Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 24, 2019
Primary completion
Oct 7, 2021
Completion
Feb 26, 2027
Last update posted
May 7, 2026

2019 – 2027

United States locations

U.S. sites
47
U.S. states
29
U.S. cities
43
Facility City State ZIP Site status
Urology Centers Of Alabama Homewood Alabama 35209
Mayo Clinic Arizona Phoenix Arizona 85054
Urological Associates of Southern Arizona, P.C. Tucson Arizona 85741
Arkansas Urology Little Rock Arkansas 72211
Kaiser Permanente Riverside California 92505
San Bernardino Urological Associates San Bernardino California 92404
University of California San Francisco San Francisco California 94158
Sansum Clinic Pharm Santa Barbara California 93105
The Urology Center of Colorado Denver Colorado 80211
Colorado Clinical Research Lakewood Colorado 80228
VA Connecticut Healthcare West Haven Connecticut 06516
Bay Pines VA Healthcare System Bay Pines Florida 33744
Advanced Urology Institute Daytona Beach Florida 32114
University of Florida Health Jacksonville Jacksonville Florida 32209
Mayo Clinic - Division Of Hematology/oncology Jacksonville Florida 32224
Veterans Affairs Medical Ctr Hines Illinois 60141
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana 46825
First Urology Jeffersonville Indiana 47130
University of Kansas Medical Center Kansas City Kansas 66160
Norton Healthcare Louisville Kentucky 40202
Ochsner Clinic Foundation New Orleans Louisiana 70121
Rcca Md, Llc Bethesda Maryland 20817
Chesapeake Urology Research Associates Towson Maryland 21204
Massachusetts General Boston Massachusetts 02114
Michigan Institute of Urology Troy Michigan 48084
Kansas City Veterans Affairs Medical Center Kansas City Missouri 64128
Adult Pediatric Urology & Urogynecology, P.C Omaha Nebraska 68114
Nebraska Cancer Specialists Omaha Nebraska 68130
Comprehensive Cancer Centers of Nevada Las Vegas Nevada 89169
Delaware Valley Urology, LLC Mount Laurel New Jersey 08054
New York Oncology Hematology Albany New York 12208
Icahn School of Medicine at Mount Sinai - The Derald H. Ruttenberg New York New York 10029
Memorial Sloan Kettering Cancer Center New York New York 10065
Upstate Cancer Center Syracuse New York 13210
Helios Clinical Research, LLC Middleburg Heights Ohio 44130
Oregon Urology Institute Springfield Oregon 97477
MidLantic Urology Bala-Cynwyd Pennsylvania 19004
Lancaster Urology Lancaster Pennsylvania 17604
VA Pittsburgh Pittsburgh Pennsylvania 15240
Carolina Urologic Research Center Myrtle Beach South Carolina 29572
Urology Associates Nashville Tennessee 37209
Houston Metro Urology Houston Texas 77027
University of Texas MD Anderson Cancer Center Houston Texas 77030
Utah Cancer Specialists Salt Lake City Utah 84106
Salem VA Medical Center Salem Virginia 80113
Urology of Virginia, PLCC Virginia Beach Virginia 23462
NorthWest Medical Specialties, PLLC Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 271 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03748641, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 7, 2026 · Synced May 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03748641 live on ClinicalTrials.gov.

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