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

Gustave Roussy

Status and phase: Suspended; Phase 2

Conditions: Prostate Cancer

Treatments: Procedure: laparoscopic radical prostatectomy; Drug: docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00127088

Peri-op

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)