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NCT02677896 · OUTCOME

PSA Undetectable Rate

A Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) · Source last updated 2025-10-24

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 baseline to detectable PSA values (maximum duration was 26.6 months)

What was measured

The PSA undetectable rate was defined as the percentage of participants with undetectable (\< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.

Analysis population: ITT with detectable PSA at baseline

Groups in this outcome

Enzalutamide + Androgen Deprivation Therapy (ADT)

Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

Placebo + Androgen Deprivation Therapy (ADT)

Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.

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

Analysis denominator · Participants

GroupSource count
Enzalutamide + Androgen Deprivation Therapy (ADT)511
Placebo + Androgen Deprivation Therapy (ADT)506

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide + Androgen Deprivation Therapy (ADT)68.1Not reported63.972.1Not reported
Placebo + Androgen Deprivation Therapy (ADT)17.6Not reported14.421.2Not reported

Source statistical analyses

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

  1. ci Lower Limit
    45.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    55.7
    group Description
    PSA Undetectable Rate Treatment Comparison
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
    param Type
    Difference in rate
    param Value
    50.5
    statistical Method
    Cochran-Mantel-Haenszel
Complete source fields
analyses
  1. ci Lower Limit
    45.3
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    55.7
    group Description
    PSA Undetectable Rate Treatment Comparison
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    p Value Comment
    Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
    param Type
    Difference in rate
    param Value
    50.5
    statistical Method
    Cochran-Mantel-Haenszel
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.9
        upper Limit
        72.1
        value
        68.1
      2. group Id
        OG001
        lower Limit
        14.4
        upper Limit
        21.2
        value
        17.6
denoms
  1. counts
    1. group Id
      OG000
      value
      511
    2. group Id
      OG001
      value
      506
    units
    Participants
description
The PSA undetectable rate was defined as the percentage of participants with undetectable (\< 0.2 ng/mL) PSA values at any time during study treatment, of those participants with detectable (≥ 0.2 ng/mL) PSA values at baseline.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    OG000
    title
    Enzalutamide + Androgen Deprivation Therapy (ADT)
  2. description
    Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
    id
    OG001
    title
    Placebo + Androgen Deprivation Therapy (ADT)
param Type
NUMBER
population Description
ITT with detectable PSA at baseline
reporting Status
POSTED
time Frame
From baseline to detectable PSA values (maximum duration was 26.6 months)
title
PSA Undetectable Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice