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

• Status: Suspended
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Treatments: Docetaxel

Criteria

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