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NCT02975934 · OUTCOME

Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF

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
MEAN
Unit
units on a scale
Interval / dispersion
Standard Error
Time frame
From enrollment to up to approximately 25 weeks

What was measured

Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.

Analysis population: ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.

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
Rucaparib133
Abiraterone Acetate or Enzalutamide or Docetaxel32

Reported measurements

BPI-SF Pain Score

Analysis denominator · Participants

GroupSource count
Rucaparib133
Abiraterone Acetate or Enzalutamide or Docetaxel32
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Rucaparib-0.320.139Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide or Docetaxel0.140.285Not reportedNot reportedNot reported
BPI-SF Interference Score

Analysis denominator · Participants

GroupSource count
Rucaparib130
Abiraterone Acetate or Enzalutamide or Docetaxel31
Values in units on a scale · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Rucaparib-0.280.147Not reportedNot reportedNot reported
Abiraterone Acetate or Enzalutamide or Docetaxel0.650.302Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.139
        value
        -0.32
      2. group Id
        OG001
        spread
        0.285
        value
        0.14
    denoms
    1. counts
      1. group Id
        OG000
        value
        133
      2. group Id
        OG001
        value
        32
      units
      Participants
    title
    BPI-SF Pain Score
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.147
        value
        -0.28
      2. group Id
        OG001
        spread
        0.302
        value
        0.65
    denoms
    1. counts
      1. group Id
        OG000
        value
        130
      2. group Id
        OG001
        value
        31
      units
      Participants
    title
    BPI-SF Interference Score
denoms
  1. counts
    1. group Id
      OG000
      value
      133
    2. group Id
      OG001
      value
      32
    units
    Participants
description
Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
dispersion Type
Standard Error
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
MEAN
population Description
ITT Population with BRCA mutated mCRPC. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number analyzed' = participants evaluable for specified category.
reporting Status
POSTED
time Frame
From enrollment to up to approximately 25 weeks
title
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
type
SECONDARY
unit Of Measure
units on a scale

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

Preserved source evidence · Not medical advice