Prostate Cancer Clinical Trial
Official title:
Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy
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.
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. ;
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