Conditions: Neoplasms Prostatic Neoplasms
Keywords: Cancer Prostate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 755
Healthy volunteers: no

Brief summary:
This is a randomized, open-label, multi-center study comparing the safety and efficacy of XRP6258 plus prednisone to mitoxantrone plus prednisone in the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere®-containing regimen. The primary objective is overall survival. Secondary objectives include progression free survival, overall response rate, prostate-specific antigen (PSA) response/progression, pain response/progression, overall safety, and pharmacokinetics. Patients will be treated until disease progression, death, unacceptable toxicity, or for a maximum of 10 cycles. Patients will have long-term follow-up for a maximum of up to 2 years.

Detailed description:

Arms:
arm 1: Mitoxantrone + Prednisone arm 2: Cabazitaxel + Prednisone

Interventions: intervention 1: cabazitaxel (XRP6258) (RPR116258) intervention 2: mitoxantrone intervention 3: prednisone
Intervention descriptions: intervention 1: 25 mg/m\^2 administered by intravenous (IV) route over 1 hour on day 1 of each 21-day cycle intervention 2: 12 mg/m\^2 administered by intravenous (IV) route over 15-30 minutes on day 1 of each 21-day cycle intervention 3: 10 mg daily administered by oral route

Protocol document: