Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent

• Status: Completed
• Trial end date: 2021-03-15

Summary

Primary Objective:

To compare the radiographic progression-free survival (rPFS) [using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for tumor lesions and Prostate Cancer Working Group 2 (PCWG2) criteria for bone scan lesions or death due to any cause] with chemotherapy (cabazitaxel plus prednisone, Arm A) versus Androgen Receptor (AR)-targeted therapy (enzalutamide or abiraterone acetate plus prednisone, Arm B) in mCRPC patients who have been treated with docetaxel and who had disease progression while receiving AR-targeted therapy within 12 months of AR treatment initiation (≤12 months, either before or after docetaxel).

Secondary Objective:

• To compare efficacy for:

• Prostate-specific antigen (PSA) response rate and time to PSA progression (TTPP).

• Progression-free survival (PFS).

• Overall survival (OS).

• Tumor response rate and duration of tumor response.

• Pain response and time to pain progression.

• Symptomatic skeletal event (SSE) rate and time to occurrence of any SSE.

• Health status and Health-related Quality of Life (HRQOL).

• To evaluate the correlation of a signature of resistance to AR-targeted agents with clinical outcome via the analysis of circulating tumor cell (CTC) phenotypes as well as expression and localization of proteins including AR isoforms in CTCs.

• To evaluate safety in the 2 treatment arms.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Abiraterone Acetate; Docetaxel; Prednisone