NCT02319837 · OUTCOME

Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total 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 to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)

What was measured

Time to first deterioration of the FACT-P total score was defined as the time from randomization to first assessment with at least a 10-point decrease from baseline in the FACT-P total score. FACT-P total score is based on subscale scores of physical, social/family, emotional, and functional well-being, as well as 12 site-specific items to assess prostate-related symptoms, ranging 0-156, with higher score representing better quality of life.

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

Group	Source count
Enzalutamide + Leuprolide	355
Placebo + Leuprolide	358
Enzalutamide Monotherapy	355

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide + Leuprolide	8.3	Not reported	5.7	11.1	Not reported
Placebo + Leuprolide	11.1	Not reported	8.3	14.0	Not reported
Enzalutamide Monotherapy	8.4	Not reported	5.8	13.0	Not reported

Source statistical analyses

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

ci Lower Limit
0.954
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.357
group Ids
OG000
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
0.1567
param Type
Hazard Ratio (HR)
param Value
1.138
statistical Method
Log Rank
ci Lower Limit
0.981
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.391
group Ids
OG001
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
0.0855
param Type
Hazard Ratio (HR)
param Value
1.168
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.954
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.357
group Ids
OG000
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
0.1567
param Type
Hazard Ratio (HR)
param Value
1.138
statistical Method
Log Rank
ci Lower Limit
0.981
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.391
group Ids
OG001
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
0.0855
param Type
Hazard Ratio (HR)
param Value
1.168
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
5.7
upper Limit
11.1
value
8.3
group Id
OG001
lower Limit
8.3
upper Limit
14.0
value
11.1
group Id
OG002
lower Limit
5.8
upper Limit
13.0
value
8.4

denoms

counts
group Id
OG000
value
355
group Id
OG001
value
358
group Id
OG002
value
355
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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
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
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 to first assessment with at least a 10-point decrease from baseline in the FACT-P total score (up to Month 98)

title

Time From Randomization to First Assessment With at Least a 10-point Decline (Deterioration) From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice