Cabazitaxel at 20 mg/m² Compared to 25 mg/m² With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer — PROSELICA  

Prostate Cancer Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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 patients 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 is 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), PSA progression, pain progression or death due to any cause

• Prostate-Specific Antigen (PSA)-Progression

• Pain progression

• Tumor response in patients with measurable disease (RECIST 1.1).

• PSA response

• Pain response in patients with stable pain at baseline.

• To compare Health-related Quality of Life (HRQL)

• To assess the pharmacokinetics and pharmacogenomics of cabazitaxel

Clinical Trial Description

Patients will be treated until progressive disease, unacceptable toxicity, patient's refusal of further study treatment or for a maximum of 10 cycles. All patients will be 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01308580
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 3
• Start date: April 2011
• Completion date: August 2015