NCT01576029

Continued Treatment With Docetaxel Versus Switch to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in Patients With Castration-Resistant Metastatic Prostate Cancer

Phase II Randomized Study of Continuing Treatment With Docetaxel Versus Switching to Cabazitaxel After Minor Prostate Specific Antigen Response to Docetaxel in the First Line Treatment of Patients With Castration-Resistant Metastatic Prostate Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: * To compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to PSA (Prostatic Specific Antigen) progression (TTP-PSA), in patients with Castration-Resistant Prostate Cancer (CRPC) that, after four cycles of docetaxel, have minor PSA response (defined as a reduction between 1% and 49%) or increase of up to 24% in PSA levels. Secondary Objectives: * PSA response rate * Overall survival (OS) * Incidence of Adverse Events

Detailed description

Screening: 21days (+7 days) Treatment: until PSA progression Post-treatment Follow-up: 2 years

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	CABAZITAXEL (XRP6258)	Pharmaceutical form: solution Route of administration: intravenous
DRUG	DOCETAXEL (XRP6976)	Pharmaceutical form: solution Route of administration: intravenous

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-04-12
• Last updated: 2013-12-24

Locations

8 sites across 1 country: Brazil