OncRef

Clinical Trial: NCT03748641

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Janssen Research & Development, LLC
Information Provided By:Janssen Research & Development, LLC
Last Update Posted:2026-09-25

Study Overview

Brief Summary

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.

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

Conditions

Castration-Resistant Prostatic Cancer

Intervention / Treatment

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

Other Study ID Numbers

  • CR108534
  • 64091742PCR3001
  • 2017-003364-12
  • 2023-503254-12-00
  • 2023
  • 2017

Start Date (Actual)

2019-01-25

Primary Completion Date (Actual)

2021-10-08

Study Completion Date (Estimated)

2027-12-31

Enrollment (Actual)

765

Study Type

Interventional

Phase

Phase 3