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ARCHES
Placebo
With LHRH
agonist/antagonist or
bilateral orchiectomy
Enzalutamide
160 mg QD
With LHRH
agonist/antagonist 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.
www.clinicaltrials.gov(NCT02677896).
Phase III Randomized, Double-blind study in mHSPC