Docetaxel in the Treatment of Hormone Refractory Prostate Cancer

Phase 4

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: docetaxel

• Registration Number: NCT00280098
• Lead Sponsor: Sanofi

Brief Summary

Evaluation of safety and efficacy of docetaxel in the treatment of advanced hormone refractory prostate cancer under the conditions of daily practise.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-18
• Study First Submitted QC: 2006-01-18
• Study First Posted: 2006-01-20
• Primary Completion: 2007-10
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Patients with advanced prostate cancer, without previous chemotherapy, progressing on hormonal treatment, performance status 1 to 2

Exclusion Criteria

• Other cytostatic treatment, other malignity, severe comorbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single group	docetaxel	-

Primary Outcome Measures

Name	Time	Method
PSA decline	after each docetaxel administration and after the end of treatment
pain response	after each docetaxel administration and after the end of treatment
side effects occurrence	Throughout the study

Trial Locations

Locations (1)

Sanofi-Aventis; 🇨🇿 Prague, Czech Republic