Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients
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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.
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Patients infected by the Human Immunodeficiency Virus (HIV)
Contra-indication to general anesthesia or surgery