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NCT02975934 · OUTCOME

Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration

A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency · Source last updated 2025-07-25

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
From enrollment to 6 months

What was measured

Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria.

Analysis population: The Safety Population included all participants with BRCA mutated mCRPC who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff.

Groups in this outcome

Rucaparib

Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.

Abiraterone Acetate or Enzalutamide or Docetaxel

Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.

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

Analysis denominator · Participants

GroupSource count
Rucaparib200
Abiraterone Acetate or Enzalutamide or Docetaxel97

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rucaparib63.0Not reportedNot reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide or Docetaxel22.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        63.0
      2. group Id
        OG001
        value
        22.7
denoms
  1. counts
    1. group Id
      OG000
      value
      200
    2. group Id
      OG001
      value
      97
    units
    Participants
description
Defined as the percentage of participants with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria.
groups
  1. description
    Oral rucaparib (monotherapy). Rucaparib: Rucaparib will be administered daily.
    id
    OG000
    title
    Rucaparib
  2. description
    Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). Abiraterone acetate or Enzalutamide or Docetaxel: Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
    id
    OG001
    title
    Abiraterone Acetate or Enzalutamide or Docetaxel
param Type
NUMBER
population Description
The Safety Population included all participants with BRCA mutated mCRPC who received at least one dose of protocol-specified treatment and had 6 months of follow-up prior to the data cutoff.
reporting Status
POSTED
time Frame
From enrollment to 6 months
title
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice