Available IPD datapackage for study 'Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen'

Primary Objective:

- To demonstrate the non inferiority in term of overall survival (OS) of Cabazitaxel 20 mg/m²
(Arm A) versus Cabazitaxel 25 mg/m² (Arm B) in combination with prednisone in participants
with metastatic castration resistant prostate cancer (mCRPC) previously treated with a
docetaxel-containing regimen.

Secondary Objectives:

- To evaluate safety in the 2 treatment arms and to assess if Cabazitaxel 20 mg/m² was
better tolerated than Cabazitaxel 25 mg/m².

- To compare efficacy of Cabazitaxel at 20 mg/m² and 25 mg/m² for:

- Progression Free Survival (PFS) defined as the first occurrence of any of the
following events: tumor progression per Response Evaluation Criteria In Solid
Tumors (RECIST), prostate-specific antigen (PSA) progression, pain progression or
death due to any cause;

- PSA Progression;

- Pain progression;

- Tumor response in participants with measurable disease (RECIST 1.1);

- PSA response;

- Pain response in participants with stable pain at baseline.

- To compare Health-related Quality of Life (HRQoL).

- To assess the pharmacokinetics and pharmacogenomics of Cabazitaxel.