COU-AA-302
•
Phase 3 multicenter, randomized, double-blind, placebo-controlled study conducted
at 151 sites in 12 countries; USA, Europe, Australia, Canada
•
Stratification by ECOG performance status 0 vs. 1
AA 1000 mg daily
Prednisone 5 mg BID
(Actual n = 546)
Co-Primary:
•
rPFS by central review
•
OS
Secondary:
•
Time to opiate use (cancer-related
pain)
•
Time to initiation of chemotherapy
•
Time to ECOG-PS deterioration
•
TTPP
Efficacy end points
Placebo daily
Prednisone 5 mg BID
(Actual n = 542)
R
A
N
D
O
M
I
Z
E
D
1:1
•
Progressive chemo-naïve
mCRPC patients
(Planned N = 1088)
•
Asymptomatic or mildly
symptomatic
Patients
de Bono, J.S. et al. NEJM: 2011.
