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NCT02952534 · OUTCOME

Time to PSA Progression by Gene

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
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.

What was measured

A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.

Analysis population: All patients who had a PSA value at baseline.

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 Mutation6.5Not reported5.77.5Not reported
ATM Mutation3.1Not reported2.83.7Not reported
CDK12 Mutation3.5Not reported2.84.6Not reported
CHEK2 Mutation5.6Not reported2.8NAThe upper confidence interval was not assessable due to insufficient number of participants with events.
Other Gene Mutation5.3Not reported3.09.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.7
        upper Limit
        7.5
        value
        6.5
      2. group Id
        OG001
        lower Limit
        2.8
        upper Limit
        3.7
        value
        3.1
      3. group Id
        OG002
        lower Limit
        2.8
        upper Limit
        4.6
        value
        3.5
      4. comment
        The upper confidence interval was not assessable due to insufficient number of participants with events.
        group Id
        OG003
        lower Limit
        2.8
        upper Limit
        NA
        value
        5.6
      5. group Id
        OG004
        lower Limit
        3.0
        upper Limit
        9.1
        value
        5.3
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 time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.
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 who had a PSA value at baseline.
reporting Status
POSTED
time Frame
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
title
Time to PSA Progression by Gene
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice