Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients

Phase 2

Suspended

• Conditions: Prostate Cancer

• Registration Number: NCT00127088
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

This is a prospective phase II study of peri-operative docetaxel plus laparoscopic radical prostatectomy in patients with localized Gleason 7 pT2a-pT2b adenocarcinoma of the prostate and a risk of relapse after radical prostatectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-08-03
• Study First Submitted QC: 2005-08-03
• Study First Posted: 2005-08-05
• Status Verified: 2006-09
• Last Update Submitted: 2006-09-07
• Last Update Posted: 2006-09-11

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

• Patients older than 18 years and less than 70 years
• Histologically-proven Gleason 7 adenocarcinoma of the prostate
• pT2a or pT2b disease based on biopsies of the prostate
• More than 2/3 of positive biopsies or 15 ≤ serum PSA <20
• No previous carcinoma, except basal-cell carcinoma of the skin
• Adequate renal function: measured or calculated creatinine clearance> 60 ml/min
• Absolute granulocyte count ≥ 1,500/mm3, platelets ≥ 100,000 mm3, bilirubin ≤ 1.5 fold the upper normal value
• Signed informed consent.

Exclusion Criteria

• Patients infected by the Human Immunodeficiency Virus (HIV)
• Contra-indication to general anesthesia or surgery
• Patients who do not fit inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete prostate specific antigen (PSA) response rate

Secondary Outcome Measures

Name	Time	Method
Toxicity
Pathological response rate
Progression free survival
Overall survival

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France