Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer — PROSPECTA  

Prostate Cancer Clinical Trial

Official title: A Phase IV, Multicenter, National, Non-comparative, Open-label Study of Cabazitaxel, Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Second-line Treatment of Patients With Metastatic Castration-resistant Prostate Cancer and After Failure of Docetaxel-based Chemotherapy. Descriptive Assessment of the Circulating Tumor Cells in This Context.

Status Completed

Clinical Trial Summary

Primary Objective:

• To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation.

Secondary Objectives:

• PSA response rate;

• Descriptive assessment of CTC (circulating Tumor Cells);

• Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period;

• Description of the Health Quality of Life of the patients;

• Incidence of adverse events.

Clinical Trial Description

Screening: 15 days Treatment: until disease progression Post-treatment Follow-up: 12 months ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neutropenia
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01649635
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 4
• Start date: July 2012
• Completion date: June 2016