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NCT01664923 · OUTCOME

Time to PSA Progression

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
MEDIAN
Unit
months
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

PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.

Analysis population: Intent-to-treat population: all participants randomly assigned to study treatment.

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
Enzalutamide198
Bicalutamide198

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
EnzalutamideNANot reported19.4NAThe median time to PSA progression and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis.
Bicalutamide8.3Not reported5.78.5Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.137
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.264
    estimate Comment
    Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.
    param Type
    Hazard Ratio (HR)
    param Value
    0.190
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.137
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.264
    estimate Comment
    Hazard ratio is based on a Cox regression model (with treatment as the only covariate) stratified by disease stage at study entry and is relative to bicalutamide with \< 1 favoring enzalutamide.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    P-value based on log-rank test stratified by disease stage at study entry as reported on the CRF.
    param Type
    Hazard Ratio (HR)
    param Value
    0.190
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median time to PSA progression and its upper limit of the 95% confidence interval were not available because an insufficient number of participants had an event at the time of analysis.
        group Id
        OG000
        lower Limit
        19.4
        upper Limit
        NA
        value
        NA
      2. group Id
        OG001
        lower Limit
        5.7
        upper Limit
        8.5
        value
        8.3
denoms
  1. counts
    1. group Id
      OG000
      value
      198
    2. group Id
      OG001
      value
      198
    units
    Participants
description
PSA progression was defined as ≥ 25% increase in PSA with an absolute increase ≥ 2 ng/mL above the nadir and was to be confirmed by a second consecutive assessment at least 3 weeks later. Participants not known to have had PSA progression were censored at the date of last PSA assessment.
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
MEDIAN
population Description
Intent-to-treat population: all participants randomly assigned to study treatment.
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
Time to PSA Progression
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice