CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 696 enrolled / 696 target
Drug / intervention
Niraparib +3 moredrug
Likely dose
Niraparib 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04497844
NCT04497844Phase 3ActiveUpdate Overdue (10.1/mo)Completion was 17mo ago
CompareCT.gov

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-Mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Janssen Research & Development, LLC·interventional·Posted Aug 4, 2020·Updated Jun 5, 2026

In Brief

A Phase 3 clinical trial evaluating Niraparib, Abiraterone acetate (AA), and 2 other interventions for Metastatic Castration-sensitive Prostate Cancer. Active but no longer recruiting, targeting 696 participants across 387 sites in 33 countries.

Signals

Enrollment appears stalled

Detailed Summary

The purpose of the study is to determine if the combination of niraparib with Abiraterone Acetate (AA) plus prednisone compared with AA plus prednisone in participants with deleterious germline or somatic Homologous Recombination Repair (HRR) gene-mutated Metastatic Castration-Sensitive Prostate Cancer (mCSPC) provides superior efficacy in improving radiographic progression-free survival (rPFS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration-sensitive Prostate Cancer
CountriesArgentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Malaysia, Mexico, Netherlands, New Zealand, Poland, Portugal, Puerto Rico, Russia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20212022202320242025202620272028
First PostedAug 4, 2020
Enrollment StartSep 23, 2020
Primary CompletionJan 7, 2025
Study CompletionNov 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 5.9 years ago

Arms & Interventions

Niraparib with Abiraterone Acetate plus Prednisone (AAP)experimental

Participants will receive the following in each 28-day treatment cycle: niraparib 200 milligrams (mg), abiraterone acetate (AA) 1000 mg plus prednisone 5 mg once daily.

Drug: NiraparibDrug: Abiraterone acetate (AA)Drug: Prednisone
AA plus Prednisone (AAP)active_comparator

Participants will receive the following in each 28-day treatment cycle: matching placebo for Niraparib along with AA 1000 mg plus prednisone 5 mg once daily.

Drug: Abiraterone acetate (AA)Drug: PrednisoneDrug: Placebo for Niraparib

Interventions

Niraparibdrug

Participants will receive Niraparib 200 mg once daily.

Abiraterone acetate (AA)drug

Participants will receive AA 1000 mg once daily.

Prednisonedrug

Participants will receive prednisone 5 mg once daily.

Placebo for Niraparibdrug

Participants will receive matching placebo for Niraparib once daily.