Cabazitaxel Versus the Switch to Alternative AR Targeted Therapy Enzalutamide or Abiraterone in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Primary Resistant Patients to Abiraterone or Enzalutamide

• Status: Terminated
• Trial end date: 2018-05-10

Summary

Primary Objective:

To demonstrate the superiority in term of radiographic Progression-Free Survival (rPFS) of cabazitaxel at at 25 milligram per meter square (mg/m^2) plus prednisone (Arm A) versus either enzalutamide at 160 milligram (mg) once daily or abiraterone acetate at 1000 mg once daily plus prednisone (Arm B) in chemotherapy-naïve participants with metastatic Castration-Resistant Prostate Cancer (mCRPC) who have disease progression while receiving androgen receptor (AR) targeted therapy (abiraterone plus prednisone or enzalutamide) within 12 months of treatment initiation (≤12 months).

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 in participants with measurable disease (RECIST 1.1)

• Pain response and time to pain progression.

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

• To analyze messenger ribonucleic acids (mRNAs) including androgen-receptor splice variant 7 messenger RNA (AR-V7) as a biomarker in Circulating Tumor Cells (CTCs).

• To evaluate safety in the 2 treatment arms.

• Phase: Phase 2

Details

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