Page 13 - Flipbook

PROTEUS

Randomization: 1:1 to APA (240 mg) plus ADT (LHRHa) or PBO plus ADT

1,500 Pts

6 treatment cycles, followed by RP, followed by an additional 6 cycles.

Dual primary end points: pCR rate (to be assessed by blinded independent

central pathology review) and MFS (to be assessed by blinded independent

central radiology review [BICR]).

Secondary end points: PSA-free survival and progression-free survival