NCT02677896 · OUTCOME

Time to Deterioration in Urinary Symptoms

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: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)

What was measured

In participants with deterioration, the time to deterioration was calculated as the time interval between randomization and the first deterioration in urinary symptoms at any postbaseline visit. A deterioration in urinary symptoms was defined as an increase in the Quality of Life Prostate-specific Questionnaire (QLQ-PR25) modified urinary symptoms. Subscale score by ≥ 50% of the standard deviation observed in the QLQ-PR25 modified urinary symptoms subscale score at baseline. Modified urinary symptoms subscale score consisted of 3-items (Q31 - Q33) from the QLQ-PR25, each scored from 1 (not at all) to 4 (very much). The total modified urinary symptoms subscale score ranges from 0-100, with higher scores represents a higher level of symptomatology/problems. In participants without deterioration in urinary symptoms, the time to deterioration in urinary symptoms was censored on the date the last urinary symptoms QLQ-PR25 score was calculable.

Analysis population: ITT

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

Group	Source count
Enzalutamide + Androgen Deprivation Therapy (ADT)	574
Placebo + Androgen Deprivation Therapy (ADT)	576

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Enzalutamide + Androgen Deprivation Therapy (ADT)	NA	Not reported	19.35	NA	Not reached. Data was not reached due to low number of events.
Placebo + Androgen Deprivation Therapy (ADT)	16.8	Not reported	14.06	NA	Not reached. Data was not reached due to low number of events.

Source statistical analyses

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

ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.08
estimate Comment
Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
group Description
Time to Deterioration of Urinary Symptoms Treatment Comparison
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2162
p Value Comment
Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
param Type
Cox hazard ratio
param Value
0.88
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.72
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
1.08
estimate Comment
Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
group Description
Time to Deterioration of Urinary Symptoms Treatment Comparison
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.2162
p Value Comment
Stratified by volume of disease (low vs high) and prior docetaxel use (yes vs no) during screening period.
param Type
Cox hazard ratio
param Value
0.88
statistical Method
Log Rank

classes

categories
measurements
comment
Not reached. Data was not reached due to low number of events.
group Id
OG000
lower Limit
19.35
upper Limit
NA
value
NA
comment
Not reached. Data was not reached due to low number of events.
group Id
OG001
lower Limit
14.06
upper Limit
NA
value
16.8

denoms

counts
group Id
OG000
value
574
group Id
OG001
value
576
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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)
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

MEDIAN

population Description

ITT

reporting Status

POSTED

time Frame

From date of randomization to the first deterioration in urinary symptoms at any postbaseline visit (maximum duration was 26.6 months)

title

Time to Deterioration in Urinary Symptoms

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice