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NCT02952534 · OUTCOME

Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency · Source last updated 2023-06-09

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
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.

What was measured

A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.

Analysis population: All patients

Groups in this outcome

BRCA Mutation

Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.

ATM Mutation

Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.

CDK12 Mutation

Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.

CHEK2 Mutation

Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.

Other Gene Mutation

Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.

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

Analysis denominator · Participants

GroupSource count
BRCA Mutation172
ATM Mutation59
CDK12 Mutation14
CHEK2 Mutation7
Other Gene Mutation25

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
BRCA Mutation10.7Not reported8.713.2Not reported
ATM Mutation5.3Not reported3.78.9Not reported
CDK12 Mutation3.7Not reported1.98.3Not reported
CHEK2 Mutation9.4Not reported2.1NAThe upper confidence interval was not assessable due to insufficient number of participants with events.
Other Gene Mutation11.6Not reported5.125.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8.7
        upper Limit
        13.2
        value
        10.7
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        8.9
        value
        5.3
      3. group Id
        OG002
        lower Limit
        1.9
        upper Limit
        8.3
        value
        3.7
      4. comment
        The upper confidence interval was not assessable due to insufficient number of participants with events.
        group Id
        OG003
        lower Limit
        2.1
        upper Limit
        NA
        value
        9.4
      5. group Id
        OG004
        lower Limit
        5.1
        upper Limit
        25.3
        value
        11.6
denoms
  1. counts
    1. group Id
      OG000
      value
      172
    2. group Id
      OG001
      value
      59
    3. group Id
      OG002
      value
      14
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      25
    units
    Participants
description
A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.
    id
    OG000
    title
    BRCA Mutation
  2. description
    Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.
    id
    OG001
    title
    ATM Mutation
  3. description
    Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.
    id
    OG002
    title
    CDK12 Mutation
  4. description
    Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.
    id
    OG003
    title
    CHEK2 Mutation
  5. description
    Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
    id
    OG004
    title
    Other Gene Mutation
param Type
MEDIAN
population Description
All patients
reporting Status
POSTED
time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
title
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice