NCT02677896 · FLOW

Participant flow

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.

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 luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.
id
FG000
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
FG001
title
Placebo + Androgen Deprivation Therapy (ADT)

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
117
group Id
FG001
num Subjects
197
type
Death
reasons
group Id
FG000
num Subjects
12
group Id
FG001
num Subjects
15
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
6
type
Progressive disease
reasons
group Id
FG000
num Subjects
41
group Id
FG001
num Subjects
71
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
30
group Id
FG001
num Subjects
99
type
Miscellaneous
reasons
group Id
FG000
num Subjects
370
group Id
FG001
num Subjects
182
type
Continued in OLE
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
4
type
Discontinued by Sponsor
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
2
type
Randomized, Not Treated
milestones
achievements
group Id
FG000
num Subjects
574
group Id
FG001
num Subjects
576
type
STARTED
achievements
group Id
FG000
num Subjects
572
group Id
FG001
num Subjects
574
type
Treated
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
574
group Id
FG001
num Subjects
576
type
NOT COMPLETED
title
Double Blind Period (up to 35 Months)
drop Withdraws
reasons
group Id
FG000
num Subjects
73
group Id
FG001
num Subjects
26
type
Death
reasons
group Id
FG000
num Subjects
8
group Id
FG001
num Subjects
3
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
22
group Id
FG001
num Subjects
10
type
Progressive disease
reasons
group Id
FG000
num Subjects
16
group Id
FG001
num Subjects
13
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
241
group Id
FG001
num Subjects
125
type
Miscellaneous
reasons
group Id
FG000
num Subjects
10
group Id
FG001
num Subjects
5
type
Discontinued by Sponsor
milestones
achievements
comment
Eligible participants who provided consent took part in open-label period
group Id
FG000
num Subjects
370
comment
Eligible participants who provided consent took part in open-label period
group Id
FG001
num Subjects
182
type
STARTED
achievements
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
370
group Id
FG001
num Subjects
182
type
NOT COMPLETED
title
Open-Label Extension (Approx. 66 Months)

pre Assignment Details

The randomization was stratified by volume of disease (low vs high) and prior docetaxel therapy for prostate cancer (no prior docetaxel, 1 to 5 cycles, 6 cycles).

recruitment Details

Participants with metastatic hormone sensitive prostate cancer (mHSPC) were enrolled in 204 study sites worldwide.

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