Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00974311 · OUTCOME

Time to Prostate-specific Antigen (PSA) Progression

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy · Source last updated 2018-12-11

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
Baseline and at every study visit from Week 13 while on study drug (up to 24 months)

What was measured

Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a \>=25% increase and an absolute increase of \>=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a \>=25% increase and an absolute increase of \>=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).

Analysis population: ITT included all participants who were randomized into the study.

Groups in this outcome

Enzalutamide

In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).

Placebo

In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE 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
Enzalutamide800
Placebo399

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide8.3Not reported5.88.3Not reported
Placebo3.0Not reported2.93.7Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.204
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.303
    estimate Comment
    Hazard Ratio and 95% confidence interval are from Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).
    param Type
    Hazard Ratio (HR)
    param Value
    0.248
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.204
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.303
    estimate Comment
    Hazard Ratio and 95% confidence interval are from Cox regression model.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.0001
    p Value Comment
    Stratified by baseline ECOG performance status and mean Brief Pain Inventory - Short Form score (Question #3).
    param Type
    Hazard Ratio (HR)
    param Value
    0.248
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.8
        upper Limit
        8.3
        value
        8.3
      2. group Id
        OG001
        lower Limit
        2.9
        upper Limit
        3.7
        value
        3.0
denoms
  1. counts
    1. group Id
      OG000
      value
      800
    2. group Id
      OG001
      value
      399
    units
    Participants
description
Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a \>=25% increase and an absolute increase of \>=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a \>=25% increase and an absolute increase of \>=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).
dispersion Type
95% Confidence Interval
groups
  1. description
    In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
    id
    OG000
    title
    Enzalutamide
  2. description
    In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
    id
    OG001
    title
    Placebo
param Type
MEDIAN
population Description
ITT included all participants who were randomized into the study.
reporting Status
POSTED
time Frame
Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
title
Time to Prostate-specific Antigen (PSA) Progression
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice