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NCT01288911 · OUTCOME

Radiographic PFS Based on ICR Assessment

A Study of Enzalutamide Versus Bicalutamide in Castrate Men With Metastatic Prostate Cancer · Source last updated 2024-12-06

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
From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.

What was measured

Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan.

Analysis population: Full analysis set

Groups in this outcome

Enzalutamide

Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

Bicalutamide

Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide184
Bicalutamide191

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
EnzalutamideNANot reported25.6NANot reached due to the low number of events
Bicalutamide16.4Not reported11.118.1Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.36
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    Estimated by use of Cox proportional hazards model.
    group Description
    Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.36
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.74
    estimate Comment
    Estimated by use of Cox proportional hazards model.
    group Description
    Radiographic PFS based on ICR Enzalutamide Vs. Bicalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER_LEGACY
    p Value
    0.0002
    param Type
    Hazard Ratio (HR)
    param Value
    0.51
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        Not reached due to the low number of events
        group Id
        OG000
        lower Limit
        25.6
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        11.1
        upper Limit
        18.1
        value
        16.4
denoms
  1. counts
    1. group Id
      OG000
      value
      184
    2. group Id
      OG001
      value
      191
    units
    Participants
description
Radiographic PFS was calculated as the time interval from the date of randomization to the first date of radiographic disease progression. Radiographic disease progression was defined as either a progression in soft tissue on CT/MRI scan according to RECIST 1.1, and/or a progression in bone lesions (a minimum of 2 new bone lesions as compared to previous scan) on bone scan and confirmed by the next bone scan.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    OG000
    title
    Enzalutamide
  2. description
    Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
    id
    OG001
    title
    Bicalutamide
param Type
MEDIAN
population Description
Full analysis set
reporting Status
POSTED
time Frame
From randomization until the data cutoff date of 19 October 2014, median duration of treatment was 11.6 months in the enzalutamide arm and 5.8 months in the bicalutamide arm.
title
Radiographic PFS Based on ICR Assessment
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice