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NCT02975934 · OUTCOME

PSA Response 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 primary completion of study (up to approximately 5 years)

What was measured

Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.

Analysis population: ITT Population with BRCA mutated mCRPC.

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
Rucaparib201
Abiraterone Acetate or Enzalutamide or Docetaxel101

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Rucaparib54.7Not reportedNot reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide or Docetaxel26.7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        54.7
      2. group Id
        OG001
        value
        26.7
denoms
  1. counts
    1. group Id
      OG000
      value
      201
    2. group Id
      OG001
      value
      101
    units
    Participants
description
Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.
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
ITT Population with BRCA mutated mCRPC.
reporting Status
POSTED
time Frame
From enrollment to primary completion of study (up to approximately 5 years)
title
PSA Response 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