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 2

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: DOCETAXEL (XRP6976); Drug: CABAZITAXEL (XRP6258)

• Registration Number: NCT01576029
• Lead Sponsor: Sanofi

Brief 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

Study Timeline

• Study First Submitted: 2012-03-30
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Study Start: 2012-08
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-23
• Last Update Posted: 2013-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel	DOCETAXEL (XRP6976)	75 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks
Cabazitaxel	CABAZITAXEL (XRP6258)	25 mg/m2, administered as a 1-hour intravenous infusion, every 3 weeks

Primary Outcome Measures

Name	Time	Method
Median time to PSA progression	up to 60 days

Secondary Outcome Measures

Name	Time	Method
PSA response rate: Percentage of patients with a decrease of at least 50% in the PSA	up to 60 days
Overall Survival: Median time elapsed between the date of starting treatment until death by any cause	up to a maximum of 2 years
Number of patients with adverse events	up to a maximum of 2 years

Trial Locations

Locations (8)

Investigational Site Number 004; 🇧🇷 Barretos, Brazil

Investigational Site Number 001; 🇧🇷 Rio De Janeiro, Brazil

Investigational Site Number 006; 🇧🇷 Rio De Janeiro, Brazil

Investigational Site Number 007; 🇧🇷 São Paulo, Brazil

Investigational Site Number 003; 🇧🇷 Mogi das Cruzes, Brazil

Investigational Site Number 008; 🇧🇷 Brasília, Brazil

Investigational Site Number 005; 🇧🇷 Porto Alegre, Brazil

Investigational Site Number 009; 🇧🇷 Londrina, Brazil