A randomized phase II study of cabazitaxel (CAB) vs (ABI) abiraterone or (ENZ) enzalutamide in poor prognosis metastatic castration-resistant prostate cancer (mCRPC)

Abstract

Background: GETUG-12 assessed docetaxel-estramustine in patients with high-risk localized prostate cancer: the primary endpoint of relapse-free survival (RFS) was met (adjusted HR: 0.71 [95% CI: 0.54-0.94], p = 0.017) (Lancet Oncol 2015; 16: 787-94). This analysis updates RFS and assesses clinical events for the first time.Methods: Eligibility included non-pretreated high-risk localized prostate cancer, defined as ≥ 1 of the following: T3-T4, Gleason ≥8, PSA ≥20 ng/mL, pN + (stratification factors). All 413 patients had a staging pelvic lymph node dissection. Patients were randomized to goserelin for 3 years and 4 cycles of docetaxel 70 mg/m2 + estramustine 10 mg/kg/d days 1-5, every 3 weeks (ADT+DE arm) or goserelin alone (ADT arm). Local therapy (radiotherapy: 87%) was administered at 3 months. Outcomes were tested with a pre-specified order (1: RFS, 2: clinical RFS (cRFS), and 3: metastases-free survival (MFS)) by the fixed-sequence method for controlling the family-wise error rate when conducting tests for multiple endpoints. RFS events: biochemical failures, metastases, proven local relapses, use of salvage treatment, and deaths. cRFS events: metastases, proven local relapses, and deaths. MFS events: metastases and deaths.