Participant flow

A 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) · Source last updated 2026-08-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants with deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration- sensitive prostate cancer (mCSPC) were randomized to receive placebo matching to niraparib and abiraterone acetate (AA) fixed dose combination (FDC) tablets along with AA tablets (4\*250 mg tablet) and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.

   id

   FG000

   title

   Placebo With Abiraterone Acetate Plus Prednisone

2. description

   Participants with deleterious germline or somatic HRR gene-mutated mCSPC were randomized to receive niraparib and AA FDC tablets (2\* \[100 mg niraparib/500 mg AA tablet\]) along with placebo matching to AA tablet and prednisone 5 mg tablet orally, once daily from Day 1 of Cycle 1 up to 49 cycles. Each treatment cycle consisted of 28 days.

   id

   FG001

   title

   Niraparib With Abiraterone Acetate Plus Prednisone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         231

      2. group Id

         FG001

         num Subjects

         249

      type

      Ongoing

   2. reasons

      1. group Id

         FG000

         num Subjects

         106

      2. group Id

         FG001

         num Subjects

         84

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         14

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         1

      type

      Regional Crisis

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         348

      2. group Id

         FG001

         num Subjects

         348

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         348

      2. group Id

         FG001

         num Subjects

         347

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         191

      type

      BRCA Subgroup

   4. achievements

      1. group Id

         FG000

         num Subjects

         226

      2. group Id

         FG001

         num Subjects

         230

      type

      HRR Effector Subgroup

   5. achievements

      1. group Id

         FG000

         num Subjects

         348

      2. group Id

         FG001

         num Subjects

         348

      type

      All HRR

   6. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   7. achievements

      1. group Id

         FG000

         num Subjects

         348

      2. group Id

         FG001

         num Subjects

         348

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The results presented are based on the primary completion date (07 January 2025). Remaining results will be reported within a year of study completion.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice