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NCT02319837 · OUTCOME

Time From Randomization to Onset of Clinically Relevant Pain Progression, Defined as a 2-point or Greater Increase From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Question 3 Score

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) · Source last updated 2026-07-09

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 a 2-point or greater increase from baseline in the BPI-SF question 3 score (up to Month 98)

What was measured

Time to clinically relevant pain progression was defined as the time from randomization to onset of pain progression, where clinically relevant pain progression was defined as a 2-point or greater increase from baseline in the BPI-SF question 3 score. BPI-SF is a self-administered questionnaire containing 9 main questions related to pain and analgesic medication use, where question 3 (paraphrased) is "On a scale of 0 \[no pain\] to 10 \[pain as bad as you can imagine\], please rate your pain at its worst in the last 24 hours" with higher score indicating worse pain.

Analysis population: ITT population was used for analysis, and it included all participants randomly assigned to study treatment.

Groups in this outcome

Enzalutamide + Leuprolide

Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.

Placebo + Leuprolide

Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.

Enzalutamide Monotherapy

Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.

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 + Leuprolide355
Placebo + Leuprolide358
Enzalutamide Monotherapy355

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Enzalutamide + Leuprolide13.9Not reported11.919.4Not reported
Placebo + Leuprolide19.4Not reported13.824.9Not reported
Enzalutamide Monotherapy16.6Not reported12.319.4Not reported

Source statistical analyses

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

  1. ci Lower Limit
    0.894
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.301
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.
    non Inferiority Type
    OTHER
    p Value
    0.4321
    param Type
    Hazard Ratio (HR)
    param Value
    1.078
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.904
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.314
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.
    non Inferiority Type
    OTHER
    p Value
    0.3702
    param Type
    Hazard Ratio (HR)
    param Value
    1.090
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.894
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.301
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide + leuprolide.
    non Inferiority Type
    OTHER
    p Value
    0.4321
    param Type
    Hazard Ratio (HR)
    param Value
    1.078
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.904
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.314
    group Ids
    1. OG001
    2. OG002
    non Inferiority Comment
    Two-sided P-value was based on a stratified log-rank test by screening PSA, PSA doubling time, and prior hormonal therapy. Hazard ratio was based on a Cox regression model stratified by factors defined above and was relative to placebo + leuprolide with \< 1 favoring enzalutamide monotherapy.
    non Inferiority Type
    OTHER
    p Value
    0.3702
    param Type
    Hazard Ratio (HR)
    param Value
    1.090
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.9
        upper Limit
        19.4
        value
        13.9
      2. group Id
        OG001
        lower Limit
        13.8
        upper Limit
        24.9
        value
        19.4
      3. group Id
        OG002
        lower Limit
        12.3
        upper Limit
        19.4
        value
        16.6
denoms
  1. counts
    1. group Id
      OG000
      value
      355
    2. group Id
      OG001
      value
      358
    3. group Id
      OG002
      value
      355
    units
    Participants
description
Time to clinically relevant pain progression was defined as the time from randomization to onset of pain progression, where clinically relevant pain progression was defined as a 2-point or greater increase from baseline in the BPI-SF question 3 score. BPI-SF is a self-administered questionnaire containing 9 main questions related to pain and analgesic medication use, where question 3 (paraphrased) is "On a scale of 0 \[no pain\] to 10 \[pain as bad as you can imagine\], please rate your pain at its worst in the last 24 hours" with higher score indicating worse pain.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    OG000
    title
    Enzalutamide + Leuprolide
  2. description
    Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    OG001
    title
    Placebo + Leuprolide
  3. description
    Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.
    id
    OG002
    title
    Enzalutamide Monotherapy
param Type
MEDIAN
population Description
ITT population was used for analysis, and it included all participants randomly assigned to study treatment.
reporting Status
POSTED
time Frame
From randomization until a 2-point or greater increase from baseline in the BPI-SF question 3 score (up to Month 98)
title
Time From Randomization to Onset of Clinically Relevant Pain Progression, Defined as a 2-point or Greater Increase From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Question 3 Score
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice