Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1200
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Participants were treated until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. All participants were followed when on study treatment and after completion of study treatment during follow up period until death or the study cutoff date, whichever came first.

Arms:
arm 1: Cabazitaxel 20 mg/m\^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles. arm 2: Cabazitaxel 25 mg/m\^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.

Interventions: intervention 1: Cabazitaxel (XRP6258) intervention 2: Prednisone (or Prednisolone)
Intervention descriptions: intervention 1: Pharmaceutical form: Concentrate and solvent for solution for infusion

Route of administration: Intravenous intervention 2: Pharmaceutical form: Tablet

Route of administration: Oral

Protocol document: