3D Versus Robot Assisted Laparoscopic Prostatectomy.

Study Overview
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Brief Summary
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A randomized, prospective study to compare the direct and indirect costs, functional and oncologic results of 3D laparoscopic and robot assisted radical prostatectomy procedures.

Detailed Description
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The direct and indirect costs, functional and oncologic results of robot assisted radical prostatectomy (RALP) are compared to those of 3D laparoscopic radical prostatectomy. The hypothesis of the study is that the functional and oncologic results of the two operative methods are equal, but the direct costs of RAPL are significantly higher. A randomized, prospective non-inferiority study will will enroll 280 patients randomized 1:1 to both operative approaches to test this hypothesis. The primary functional outcome measure is the proportion of patients with complete urinary continence (no protective pad use) at 12 months post operatively. Secondary functional outcome measure is the preservation erectile function at 12 months post operatively. Oncologic outcome measures are the proportion of patients with undetectable post operative prostate specific antigen levels and positive surgical margins at pathological examination. The direct and indirect costs of both operative approaches are recorded.

Official Title
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3D Versus Robot Assisted Laparoscopic Prostatectomy. A Prospective Randomized Non-inferiority Study.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Radical prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Localized prostate cancer undergoing radical prostatectomy Patient has to understand and be able to write and read Finnish language No prior head injury, dementia or Parkinson's disease No concomitant malignant illness Life expectancy of at least 10 years 35-74 years of age Exclusion Criteria: Locally advanced prostate cancer (T4) Suspicion or documented metastases (M1) Serum PSA > 20 ng/ml Prior laparoscopic hernia surgery employing non resorbable mesh Prior pelvic irradiation or major surgery Prior malignant disease within prior 5 years excluding skin cancer (non-melanoma).

Ages Eligible for Study
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Minimum Age: 34 Years
Maximum Age: 74 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robot assisted prostatectomy.<br>Intervention: radical prostatectomy | Procedure: Radical prostatectomy<br>* Surgical removal of the prostate<br>* Other names: Total prostatectomy;|
| Experimental: 3D laparoscopic prostatectomy<br>Intervention: radical prostatectomy | Procedure: Radical prostatectomy<br>* Surgical removal of the prostate<br>* Other names: Total prostatectomy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence | Expanded Prostate Cancer Index Composite (EPIC) Short Form (EPIC-26), urinary domain score is used to assess the return of continence post operatively. The percentage of patients with no protective pad use at 12 months post operatively is the main outcome measure. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function | International Index of Erectile Function (IIEF-5) Questionnaire score is used to quantify the return of erectile function post operatively. | 12 months | 
| Prostate specific antigen | Post operative prostate specific antigen levels. | 12 months | 
| Evaluation of surgical margins at pathologic examination. | The oncological outcome is evaluated by the presence of cancerous tissue at the surgical margins of the specimen at pathologic examination. | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical prostatectomy, laparoscopic prostatectomy, robot assisted prostatectomy