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NCT04497844 · OUTCOME

HRR Effector 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 CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan \>= 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: HRR effector FAS included all randomized HRR effector participants classified according to their assigned treatment arm, regardless of the actual treatment received.

Groups in this outcome

HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone

Participants with deleterious germline or gene-mutated mCSPC and HRR effector gene 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.

HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone

Participants with deleterious germline or somatic HRR gene-mutated mCSPC and HRR effector gene 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
HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone226
HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone230

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone27.56Not reported25.59NAThe upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus PrednisoneNANot reported41.20NAMedian and the upper limit of the 95% 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
    0.421
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.774
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0003
    p Value Comment
    The priori threshold for statistical significance was 0.025.
    param Type
    Hazard Ratio (HR)
    param Value
    0.571
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.421
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.774
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0003
    p Value Comment
    The priori threshold for statistical significance was 0.025.
    param Type
    Hazard Ratio (HR)
    param Value
    0.571
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the 95% CI was not estimable due to an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        25.59
        upper Limit
        NA
        value
        27.56
      2. comment
        Median and the upper limit of the 95% 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
      226
    2. group Id
      OG001
      value
      230
    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 CT or MRI per RECIST 1.1; (2) progression of bone lesions observed by bone scan per PCWG3 criteria: bone progression was confirmed by subsequent scan \>= 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 gene-mutated mCSPC and HRR effector gene 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
    HRR Effector Subgroup: Placebo With Abiraterone Acetate Plus Prednisone
  2. description
    Participants with deleterious germline or somatic HRR gene-mutated mCSPC and HRR effector gene 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
    HRR Effector Subgroup: Niraparib With Abiraterone Acetate Plus Prednisone
param Type
MEDIAN
population Description
HRR effector FAS included all randomized HRR effector participants 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
HRR Effector 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