Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

Study Overview
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Brief Summary
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In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).

Official Title
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Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Robotic-Assisted Radical Prostatectomy
* Procedure: Laparoscopic Radical Prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Localized prostate cancer Gleason grade ≤ 3 + 4 PSA < 15 ng / mL Stage ≤ T2b Eligible to receive laparoscopic radical prostatectomy Candidate bilateral or unilateral erectile preservation Exclusion Criteria: Patient at high risk of postoperative progression (PSA> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3 Presenting erectile dysfunction (IIEF < 22) Past history of urinary incontinence (> grade 1 WHO) Body mass index > 30

Ages Eligible for Study
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Minimum Age: 40 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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic-Assisted Radical Prostatectomy<br>Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System | Procedure: Robotic-Assisted Radical Prostatectomy<br> <br> |
| Active Comparator: Laparoscopic Radical Prostatectomy<br>Standard laparoscopic Radical Prostatectomy | Procedure: Laparoscopic Radical Prostatectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function | Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations. | 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical margins |  | During surgery | 
| Prostate Specific Antigen (PSA) |  | Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery | 
| Continence | Continence is assessed by the International Prostate Symptom Score (IPSS) | Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery | 
| Tolerance | Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery | Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery | 
| Quality of life | Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores | Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery | 
| Incremental cost-effectiveness ratio | Economic evaluation will be made to estimate direct costs of the five postoperative years along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment | 60 months afet surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinically localized prostate cancer, Robotic-assisted prostatectomy, Laparoscopic prostatectomy, Erectile function ;, Cost efficacy study