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NCT01664923 · OUTCOME

Best Overall Soft Tissue Response

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer · Source last updated 2019-01-30

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.

What was measured

Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.

Analysis population: All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.

Groups in this outcome

Enzalutamide

Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.

Bicalutamide

Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide35
Bicalutamide43

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide60.0Not reported42.1176.13Not reported
Bicalutamide14.0Not reported5.3027.93Not reported

Source statistical analyses

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

  1. ci Lower Limit
    26.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    65.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    This secondary endpoint was not adjusted for multiple comparisons.
    param Type
    Difference in objective response rate
    param Value
    46.05
    statistical Comment
    Based on unstratified Cochran-Mantel-Haenszel mean score test.
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    26.79
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    65.30
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    This secondary endpoint was not adjusted for multiple comparisons.
    param Type
    Difference in objective response rate
    param Value
    46.05
    statistical Comment
    Based on unstratified Cochran-Mantel-Haenszel mean score test.
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        42.11
        upper Limit
        76.13
        value
        60.0
      2. group Id
        OG001
        lower Limit
        5.30
        upper Limit
        27.93
        value
        14.0
denoms
  1. counts
    1. group Id
      OG000
      value
      35
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Best overall soft tissue response is defined as partial response (PR) or complete response (CR) while on study treatment based on investigator assessment of target, nontarget, and new lesions using RECIST 1.1. Only participants in the metastatic population with measurable soft tissue disease (at least 1 target lesion identified per RECIST 1.1) at screening were included in the analysis. All percentages are based on number of participants with metastatic and measurable soft tissue disease at screening in each treatment group.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule in DB phase.
    id
    OG000
    title
    Enzalutamide
  2. description
    Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules in DB phase.
    id
    OG001
    title
    Bicalutamide
param Type
NUMBER
population Description
All participants who were randomly assigned to study treatment and had metastatic and measurable soft tissue disease at screening.
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 09 February 2015, median duration of treatment was 14.7 months in the enzalutamide arm and 8.4 months in the bicalutamide arm.
title
Best Overall Soft Tissue Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice