Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02987543 · OUTCOME

Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only

Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study) · Source last updated 2023-10-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).

What was measured

ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = \>=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.

Analysis population: Evaluable for response

Groups in this outcome

Cohort A Olaparib 300mg bd

2x150mg film-coated tablets

Cohort A Investigators Choice of NHA

either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)

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

Analysis denominator · Participants

GroupSource count
Cohort A Olaparib 300mg bd84
Cohort A Investigators Choice of NHA43

Reported measurements

Source class 1

Response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A Olaparib 300mg bd28Not reportedNot reportedNot reportedNot reported
Cohort A Investigators Choice of NHA1Not reportedNot reportedNot reportedNot reported

No response

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A Olaparib 300mg bd56Not reportedNot reportedNot reportedNot reported
Cohort A Investigators Choice of NHA42Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    4.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    379.18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    20.86
    statistical Method
    Regression, Logistic
Complete source fields
analyses
  1. ci Lower Limit
    4.18
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    379.18
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Odds Ratio (OR)
    param Value
    20.86
    statistical Method
    Regression, Logistic
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        1
      title
      Response
    2. measurements
      1. group Id
        OG000
        value
        56
      2. group Id
        OG001
        value
        42
      title
      No response
denoms
  1. counts
    1. group Id
      OG000
      value
      84
    2. group Id
      OG001
      value
      43
    units
    Participants
description
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = \>=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.
groups
  1. description
    2x150mg film-coated tablets
    id
    OG000
    title
    Cohort A Olaparib 300mg bd
  2. description
    either enzalutamide capsules (160 mg od) or abiraterone acetate tablets (1,000 mg od with 5 mg bid prednisone)
    id
    OG001
    title
    Cohort A Investigators Choice of NHA
param Type
COUNT_OF_PARTICIPANTS
population Description
Evaluable for response
reporting Status
POSTED
time Frame
Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
title
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice