Trial Information
Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery
The aim of this study is to show that radical prostatectomy by laparoscopic way could obtain
carcinological results not lower than theses with radical retropubic surgery.
Inclusion Criteria:
- Male, old patient of less than 70 years,
- having a prostate cancer proven histologically, requiring a radical prostatectomy.
- Clinical stage T1c and rate of PSA (with 20 ng/ml).
- Osseous scintiscanning and abdomen-pelvic scanner negative.
- Patient informed of the study and its participation.
- Patient affiliated to a social security system.
Exclusion Criteria:
- Contra-indication with the surgery or the anaesthesia.
- Antecedent of prostate resection or adenomectomy.
- Antecedent of inguinal hernia treatment.
- Antecedent of deep venous thrombosis of the lower limbs or pulmonary embolism
- Patient privatized of freedom.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.
Outcome Time Frame:
during the study
Safety Issue:
No
Principal Investigator
Claude ABBOU, PU-PH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assistance Publique - Hôpitaux de Paris
Authority:
France: Ministry of Health
Study ID:
K060402
NCT ID:
NCT00502723
Start Date:
December 2007
Completion Date:
July 2012
Related Keywords:
- Cancer of the Prostate
- Retropubic Prostatectomy
- Surgical Procedures
- Laparoscopic
- Prostatic Neoplasms