Multicentric Study Comparing Carcinological and Functional Results of Surgery

Phase 3

• Conditions: Cancer of the PROSTATE
• Interventions: Procedure: Radical laparoscopy prostatectomy; Procedure: Radical retropubic prostatectomy

• Registration Number: NCT00502723
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

National multicentric prospective open study, comparing two current surgical methods: laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-18
• Study Start: 2007-12
• Status Verified: 2008-01
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-27
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 1440

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Radical laparoscopy prostatectomy	Radical laparoscopy prostatectomy
1	Radical retropubic prostatectomy	Radical retropubic prostatectomy

Primary Outcome Measures

Name	Time	Method
laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer.	during the study

Secondary Outcome Measures

Name	Time	Method
Carcinological (percentage of positive surgical margins, percentage of capsular crossing).	after the surgical
Functional (urinary continence, sexuality, quality of life)	at 2 years
per and post operational morbidity	during the 36 months
economic	duration and cost of hospitalization

Trial Locations

Locations (1)

Groupe Hospitalier Albert Chenevier Henri Mondor; 🇫🇷 Creteil, France