Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy (RoboProstate)

December 5, 2025 updated by: Centre Hospitalier Universitaire de Nīmes

Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

The main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the Da Vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy.

The time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the National Health Data System).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The secondary objectives of this research are to compare the following between the two groups:

  • The actual cost of the surgical prostatectomy.
  • Erectile function at 0, 1, 6, 12 and 24
  • Oncological results at 1, 6, 12 and 24 months.
  • Functional results at 0, 1, 6, 12 and 24 months.
  • Quality of life at 0, 1, 6, 12 and 24 months.
  • Complication rates at 1 and 24 months.

Study Type

Interventional

Enrollment (Actual)

90

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
      • Marseille, France, 13385
        • APHM - Hôpital de la Conception
      • Montpellier, France, 34070
        • Clinique Beau Soleil
      • Nîmes, France, 30029
        • CHU de Nîmes - Hopital Universitaire Caremeau

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

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Study Population

Men between the ages of 45 and 75 and who have been diagnosed with localised prostate cancer. The treatment option retained is radical prostatectomy.

Description

Inclusion Criteria:

  • The patient must have given his informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 24 months of follow up
  • Patient has localised prostate cancer
  • Patient is eligible for radical prostatectomy

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • Patient has a contraindication for a treatment necessary for this study
  • Patients with psychiatric disorders

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Robotic assistance, Nîmes
The patients in this group will undergo robot-assisted radical prostatectomy at the University Hospital of Nîmes.
Procedure: Robot-assisted radical prostatectomy
Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S
Active Comparator: Laparotomy, Marseilles
The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.
Procedure: Radical prostatectomy via laparotomy
Classic radical prostatectomy via open retropubic approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall cost (€) of patient care
Time Frame: 60 months
Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 5 years. All medical resources consumed will be evaluated during the first 5 years after surgery.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost (€) of surgery via micro-costing
Time Frame: Day 1
All human and material resources necessary for carrying out a prostatectomy will be evaluated.
Day 1
Change in erectile function
Time Frame: baseline to 1 month
the International Index of Erectile Function (IIEF-15) will be used.
baseline to 1 month
Change in erectile function
Time Frame: baseline to 6 months
the International Index of Erectile Function (IIEF-15) will be used.
baseline to 6 months
Change in erectile function
Time Frame: baseline to 12 months
the International Index of Erectile Function (IIEF-15) will be used.
baseline to 12 months
Change in erectile function
Time Frame: baseline to 24 months
the International Index of Erectile Function (IIEF-15) will be used.
baseline to 24 months
the % of positive margins after resection
Time Frame: baseline (Day 1)
baseline (Day 1)
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
Time Frame: 1 month
1 month
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
Time Frame: 6 months
6 months
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
Time Frame: 12 months
12 months
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
Time Frame: 24 months
24 months
Change in function as estimated by the PR25 questionnaire
Time Frame: baseline to 1 month
baseline to 1 month
Change in function as estimated by the PR25 questionnaire
Time Frame: baseline to 6 months
baseline to 6 months
Change in function as estimated by the PR25 questionnaire
Time Frame: baseline to 12 months
baseline to 12 months
Change in function as estimated by the PR25 questionnaire
Time Frame: baseline to 24 months
baseline to 24 months
Change in quality of life as estimated by the QLQC-30 questionnaire
Time Frame: baseline to 1 month
baseline to 1 month
Change in quality of life as estimated by the QLQC-30 questionnaire
Time Frame: baseline to 6 months
baseline to 6 months
Change in quality of life as estimated by the QLQC-30 questionnaire
Time Frame: baseline to 12 months
baseline to 12 months
Change in quality of life as estimated by the QLQC-30 questionnaire
Time Frame: baseline to 24 months
baseline to 24 months
Presence/absence of complications (Clavien)
Time Frame: 1 month
The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)
1 month
Presence/absence of complications (Clavien)
Time Frame: 24 months
The Clavien classification will be used (Clavien, P.A., Sanabria J.R., et S.M. Strasberg. 1992. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Suregry 111 (5): 518-526.)
24 months
Presence/absence of complications (Pentafecta)
Time Frame: 1 month
The Pentafecta classification will be used.
1 month
Presence/absence of complications (Pentafecta)
Time Frame: 24 months
The Pentafecta classification will be used.
24 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Stéphane Droupy, MD PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

November 26, 2012

Primary Completion (Actual)

June 4, 2018

Study Completion (Actual)

March 22, 2021

Study Registration Dates

First Submitted

April 13, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (Estimated)

April 16, 2012

Study Record Updates

Last Update Posted (Estimated)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2011/SD-03
  • 2011-A01385-36 (Other Identifier: ANSM)

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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