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Placebo

With LHRH

agonist/antago

nist or

bilateral

orchiectomy

Enzalutamide

160 mg QD

With LHRH

agonist/antago

nist or

bilateral

orchiectomy

R

1:1

N=1150

mPC documented on

bone scan/ CT or MRI

Prior treatment with

docetaxel (up to 6 cycles)

ADT (LHRH) up to 3

month (or 6 month with

docetaxel) is allowed -

No radiographic evidence

of disease progression or

rising PSA levels prior to

day 1

Prior ADT given for < 39

months in duration and >

9 months before

randomization as

neoadjuvant/adjuvant

therapy.

Primary Endpoints

rPFS

(based on central review)

Secondary Endpoints

Overall Survival

Time to first SSE

Time to castration resistance

Time to deterioration of QoL

Time to initiation of new antineoplastic

therapy

Time to PSA progression (≥ 2 ng/mL)

PSA undetectable rate (< 0.2 ng/mL)

ORR

Time to pain progression

Safety Endpoints

AEs, labs, vitals, ECG, physical exams

STRATIFICATION: Volume of disease (high vs. low) and prior docetaxel

therapy (0, 1-5, 6 cycles)

www.clinicaltrials.gov

(NCT02677896).

Phase III, Randomized, Double-blind study in mHSPC