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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 765 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Castration-Resistant Prostatic Cancer

Interventions

Type	Name	Description
DRUG	Niraparib	Participants will receive niraparib 200 mg capsules or tablets once daily.
DRUG	Abiraterone Acetate	Participants will receive AA 1000 mg tablets once daily.
DRUG	Prednisone	Participants will receive prednisone 10 mg tablets daily.
DRUG	Placebo	Participants will receive matching placebo once daily.
DRUG	New Formulation of Niraparib and Abiraterone Acetate (AA)	Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.

Timeline

• Start date: 2019-01-25
• Primary completion: 2021-10-08
• Completion: 2027-02-27
• First posted: 2018-11-21
• Last updated: 2026-04-13
• Results posted: 2023-10-04

Locations

318 sites across 29 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, France, Germany, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study