XTANDI Significantly Extended Metastasis-Free Survival in Patients with Nonmetastatic CRPC
Astellas Pharma US, Inc. and Pfizer Inc. are pleased to announce that XTANDI is now indicated for the treatment of patients with CRPC.1
PROSPER was a multinational, randomized, double-blind, placebo-controlled phase 3 study of XTANDI + LHRH therapy† in patients with nonmetastatic CRPC who had progressed on LHRH therapy.†1,2 In PROSPER, 1401 patients with nonmetastatic CRPC were randomized 2:1 to receive XTANDI at a dose of 160 mg once daily (n = 933) or matching placebo once daily (n = 468).1 Treatment randomization was stratified by PSA doubling time (< 6 months or ≥ 6 months) and baseline use of a bone-targeting agent (yes or no).2 Patients in both arms continued to receive LHRH therapy† and had a PSA doubling time of 10 months or less.1 The primary endpoint was metastasis-free survival.*1 Eligibility criteria included: nonmetastatic CRPC (central review), 3 rising PSA values despite castrate testosterone levels (≤ 50 ng/dL),‡ baseline PSA at least 2 ng/mL, PSA doubling time 10 months or less, no prior chemotherapy and ECOG performance status of 0 or 1.1,2.
