Multicentric Study Comparing Carcinological and Functional Results of Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prostate Cancer: Multicentric Study Comparing Carcinological and Functional Results of Surgery

Conditions
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Cancer of the PROSTATE

Intervention / Treatment
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* Procedure: Radical retropubic prostatectomy
* Procedure: Radical laparoscopy prostatectomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2<br>Radical laparoscopy prostatectomy | Procedure: Radical laparoscopy prostatectomy<br>* Radical laparoscopy prostatectomy<br>|
| Experimental: 1<br>Radical retropubic prostatectomy | Procedure: Radical retropubic prostatectomy<br>* Radical retropubic prostatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laparoscopic way versus open retropubic way among patients requiring a radical prostatectomy for a localised prostate cancer. |  | during the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retropubic Prostatectomy, Surgical Procedures, Laparoscopic