Conditions: Prostate Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1168
Healthy volunteers: no

Brief summary:
Primary Objective:

* To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy.

Secondary Objectives:

* To evaluate safety in the 3 treatment arms.
* To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for:

  * Progression Free Survival (PFS) (RECIST 1.1)
  * Tumor progression free survival (RECIST 1.1)
  * Tumor response in participants with measurable disease (RECIST 1.1),
  * PSA response
  * PSA-Progression free survival (PSA-PFS).
  * Pain response in participants with stable pain at baseline
  * Pain progression free survival
  * Time to occurrence of any skeletal related events (SRE)
* To compare Health-Related Quality of Life (HRQL).
* To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Detailed description:
Participants were treated until progressive disease, unacceptable toxicity, or participant's refusal of further study treatment. 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 comes first.

Arms:
arm 1: Cabazitaxel 25 mg/m\^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant's refusal. arm 2: Cabazitaxel 20 mg/m\^2 IV infusion on Day 1 of each 21 -day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal. arm 3: Docetaxel (TXT) 75 mg/m\^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.

Interventions: intervention 1: Cabazitaxel (XRP6258) intervention 2: Docetaxel (XRP6976) intervention 3: Prednisone
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection; Route of administration: Intravenous intervention 2: Pharmaceutical form: Solution for injection'; Route of administration: Intravenous intervention 3: Pharmaceutical form: Tablet; Route of administration: Oral

Protocol document: