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NCT02975934 · OUTCOME

Time to Prostate Specific Antigen (PSA) Progression 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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From enrollment to primary completion of study (up to approximately 5 years)

What was measured

Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.

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 months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Rucaparib6.6Not reported5.97.7Not reported
Abiraterone Acetate or Enzalutamide or Docetaxel3.8Not reported3.14.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.9
        upper Limit
        7.7
        value
        6.6
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        4.5
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      201
    2. group Id
      OG001
      value
      101
    units
    Participants
description
Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
dispersion Type
95% Confidence Interval
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
MEDIAN
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
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice