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NCT04497844 · OUTCOME

All HRR: Time to Symptomatic Progression

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

Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture \[symptomatic and/or pathologic\], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.

Analysis population: All HRR FAS included all randomized participants classified according to their assigned treatment arm, regardless of the actual treatment received.

Groups in this outcome

Placebo With Abiraterone Acetate Plus Prednisone

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.

Niraparib With Abiraterone Acetate Plus Prednisone

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.

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

Analysis denominator · Participants

GroupSource count
Placebo With Abiraterone Acetate Plus Prednisone348
Niraparib With Abiraterone Acetate Plus Prednisone348

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Placebo With Abiraterone Acetate Plus PrednisoneNANot reported43.14NAMedian and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
Niraparib With Abiraterone Acetate Plus PrednisoneNANot reportedNANAMedian, lower and upper limit of 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
    0.364
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.695
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The priori threshold for statistical significance was 0.03207.
    param Type
    Hazard Ratio (HR)
    param Value
    0.503
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.364
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.695
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    The priori threshold for statistical significance was 0.03207.
    param Type
    Hazard Ratio (HR)
    param Value
    0.503
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Median and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        43.14
        upper Limit
        NA
        value
        NA
      2. comment
        Median, lower and upper limit of 95% CI were not estimable due to an insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      348
    2. group Id
      OG001
      value
      348
    units
    Participants
description
Time to symptomatic progression was defined as time from the date of randomization to the date of any of the following (whichever occurred first): (a) the use of external beam radiation therapy for skeletal or pelvic symptoms, (b) the need for tumor-related orthopedic surgical intervention, (c) other cancer-related procedures (example: nephrostomy insertion, bladder catheter insertion, external beam radiation therapy, or surgery for tumor symptoms), (d) cancer-related morbid events (that is, fracture \[symptomatic and/or pathologic\], cord compression, urinary obstructive events), (e) initiation of a new systemic anti-cancer therapy because of cancer symptoms.
dispersion Type
95% Confidence Interval
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
    OG000
    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
    OG001
    title
    Niraparib With Abiraterone Acetate Plus Prednisone
param Type
MEDIAN
population Description
All HRR FAS included all randomized 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
All HRR: Time to Symptomatic Progression
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice