NCT01577836

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

November 26, 2012

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2021

Completed
Last Updated

December 12, 2025

Status Verified

June 1, 2023

Enrollment Period

5.5 years

First QC Date

April 13, 2012

Last Update Submit

December 5, 2025

Conditions

Prostatic Neoplasms

Keywords

Radical prostatectomieRobotic assistanceLaparotomy

Outcome Measures

Primary Outcomes (1)

  • Overall cost (€) of patient care

    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 Outcomes (22)

  • Cost (€) of surgery via micro-costing

    Day 1

  • Change in erectile function

    baseline to 1 month

  • Change in erectile function

    baseline to 6 months

  • Change in erectile function

    baseline to 12 months

  • Change in erectile function

    baseline to 24 months

  • +17 more secondary outcomes

Study Arms (2)

Robotic assistance, Nîmes

EXPERIMENTAL

The patients in this group will undergo robot-assisted radical prostatectomy at the University Hospital of Nîmes.

Procedure: Robot-assisted radical prostatectomy

Laparotomy, Marseilles

ACTIVE COMPARATOR

The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.

Procedure: Radical prostatectomy via laparotomy

Interventions

Robot-assisted radical prostatectomyPROCEDURE

Transperitoneal robot-assisted radical prostatectomy technique with the Da Vinci S

Robotic assistance, Nîmes
Radical prostatectomy via laparotomyPROCEDURE

Classic radical prostatectomy via open retropubic approach

Laparotomy, Marseilles

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The patient is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

APHM - Hôpital de la Conception

Marseille, 13385, France

Location

Clinique Beau Soleil

Montpellier, 34070, France

Location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (1)

  • Bouvet S, Chkair S, Daures JP, Kabani S; OptiPRobot Study Group; Chevallier T, Lechevallier E, Droupy S. Robot-assisted approach versus open surgery and conventional laparoscopy for radical prostatectomy for prostate cancer: a micro-costing study. Health Econ Rev. 2025 Jul 5;15(1):55. doi: 10.1186/s13561-025-00652-5.

    PMID: 40616606RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Stéphane Droupy, MD PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2012

First Posted

April 16, 2012

Study Start

November 26, 2012

Primary Completion

June 4, 2018

Study Completion

March 22, 2021

Last Updated

December 12, 2025

Record last verified: 2023-06

Locations

FR(3)