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NCT04497844 · OUTCOME

Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization (Day -3 to Day 1) up to approximately 49 months

What was measured

rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.

Analysis population: BRCA full analysis set (FAS) included all randomized participants with BRCA gene alteration classified according to their assigned treatment arm, regardless of the actual treatment received.

Groups in this outcome

BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone

Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and 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.

BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone

Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations 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.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone196
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone191

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone25.99Not reported22.1141.17Not reported
BRCA Subgroup: Niraparib With Abiraterone Acetate Plus PrednisoneNANot reported41.20NAMedian and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.370
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.717
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The priori threshold for statistical significance was 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.515
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.370
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.717
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The priori threshold for statistical significance was 0.05.
    param Type
    Hazard Ratio (HR)
    param Value
    0.515
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22.11
        upper Limit
        41.17
        value
        25.99
      2. comment
        Median and the upper limit of the 95% confidence interval (CI) were not estimable due to an insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        41.20
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      196
    2. group Id
      OG001
      value
      191
    units
    Participants
description
rPFS: time interval from date of randomization to first date of radiographic progression as assessed by investigator or death due to any cause, whichever occurred first. rPFS was determined by: (1) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI) per response evaluation criteria in solid tumors (RECIST) 1.1; (2) progression of bone lesions observed by bone scan per prostate cancer working group 3 (PCWG3) criteria: bone progression was confirmed by subsequent scan greater than or equal to (\>=) 6 weeks later. Week 8 scan was baseline to which all subsequent scans were compared to determine progression. A confirmatory scan with \>=2 new lesions indicated progression; A confirmatory scan not showing \>=2 new lesions means no progression. If Week 8 scan shows \<2 new bone lesions compared to baseline, first scan with \>=2 new lesions compared to Week 8 scan indicated progression, when confirmed by a subsequent scan \>=6 weeks later.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with deleterious germline or mCSPC and BRCA alterations were randomized to receive placebo matching to niraparib and 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
    OG000
    title
    BRCA Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
  2. description
    Participants with deleterious germline or somatic HRR gene-mutated mCSPC and BRCA alterations 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
    OG001
    title
    BRCA Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
param Type
MEDIAN
population Description
BRCA full analysis set (FAS) included all randomized participants with BRCA gene alteration classified according to their assigned treatment arm, regardless of the actual treatment received.
reporting Status
POSTED
time Frame
From date of randomization (Day -3 to Day 1) up to approximately 49 months
title
Breast Cancer Gene (BRCA) Subgroup: Radiographic Progression-free Survival (rPFS) Assessed by Investigator
type
PRIMARY
unit Of Measure
months

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Preserved source evidence · Not medical advice