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

A Prospective Phase II of Peri-Operative Docetaxel + Laparoscopic Radical Prostatectomy in Patients With Localized Gleason 7 pT2a-pT2b Adenocarcinoma and a Risk of Relapse After Radical Prostatectomy

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.

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