Status:
SUSPENDED
Study of Peri-Operative Docetaxel Plus Laparoscopic Radical Prostatectomy in Prostate Cancer Patients
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Prostate Cancer
Eligibility:
MALE
18-70 years
Phase:
PHASE2
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 rel...
Eligibility Criteria
Inclusion
- 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
- Patients infected by the Human Immunodeficiency Virus (HIV)
- Contra-indication to general anesthesia or surgery
- Patients who do not fit inclusion criteria
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00127088
Start Date
October 1 2004
Last Update
September 11 2006
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94805