NCT01946204 · OUTCOME

Time to Metastasis (TTM)

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer · Source last updated 2026-08-31

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: Up to approximately 43 Months

What was measured

Time to metastasis (TTM) was defined as the time from randomization to the time of the scan that showed first evidence of BICR-confirmed radiographically detected bone or soft tissue distant metastasis. The TTM data for participants without metastasis were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and CT or MRI of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.

Analysis population: ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.

Groups in this outcome

Placebo

Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.

Apalutamide

Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.

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
Placebo	401
Apalutamide	806

Reported measurements

US Regulatory

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	16.59	Not reported	14.59	18.46	Not reported
Apalutamide	40.51	Not reported	NA	NA	NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).

EX-US Regulatory

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Placebo	15.70	Not reported	14.55	18.40	Not reported
Apalutamide	40.51	Not reported	31.15	40.51	Not reported

Source statistical analyses

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

ci Lower Limit
0.219
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.335
group Description
Statistical Analysis for TTM by BICR (US Regulatory)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.271
statistical Method
Log Rank
ci Lower Limit
0.227
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.342
group Description
Statistical Analysis for TTM by BICR (Ex-US Regulatory)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.279
statistical Method
Log Rank

Complete source fields

analyses

ci Lower Limit
0.219
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.335
group Description
Statistical Analysis for TTM by BICR (US Regulatory)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.271
statistical Method
Log Rank
ci Lower Limit
0.227
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.342
group Description
Statistical Analysis for TTM by BICR (Ex-US Regulatory)
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
<0.0001
param Type
Hazard Ratio (HR)
param Value
0.279
statistical Method
Log Rank

classes

categories
measurements
group Id
OG000
lower Limit
14.59
upper Limit
18.46
value
16.59
comment
NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
group Id
OG001
lower Limit
NA
upper Limit
NA
value
40.51
title
US Regulatory
categories
measurements
group Id
OG000
lower Limit
14.55
upper Limit
18.40
value
15.70
group Id
OG001
lower Limit
31.15
upper Limit
40.51
value
40.51
title
EX-US Regulatory

denoms

counts
group Id
OG000
value
401
group Id
OG001
value
806
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
id
OG000
title
Placebo
description
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
id
OG001
title
Apalutamide

param Type

MEDIAN

population Description

ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.

reporting Status

POSTED

time Frame

Up to approximately 43 Months

title

Time to Metastasis (TTM)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice