Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy (ROBOTCAP)

June 2, 2017 updated by: Hospices Civils de Lyon

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33074
        • Service d'Urologie - Clinique St Augustin
      • Lyon cedex 03, France, 69437
        • Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon
      • Paris, France, 75014
        • Service d'Urologie - Institut Mutualiste Montsouris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erectile function
Time Frame: 12 months after surgery
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
Time Frame: During surgery
During surgery
Prostate Specific Antigen (PSA)
Time Frame: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Continence
Time Frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
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
Time Frame: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
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
Time Frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
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
Time Frame: 60 months afet surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 5, 2017

Last Update Submitted That Met QC Criteria

June 2, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009.587

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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