Overview

This trial is active, not recruiting.

Condition prostatic neoplasms
Sponsor Centre Hospitalier Universitaire de Nīmes
Start date November 2012
End date April 2018
Trial size 90 participants
Trial identifier NCT01577836, 2011-A01385-36, AOI/2011/SD-03

Summary

The main objective of the study is to estimate and compare the overall cost of care of patients over 24 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
The patients in this group will undergo robot-assisted radial prostatectomy at the University Hospital of Nîmes.
The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.

Primary Outcomes

Measure
Overall cost (€) of patient care
time frame: 24 months

Secondary Outcomes

Measure
Cost (€) of surgery via micro-costing
time frame: Day 1
Change in erectile function
time frame: baseline to 1 month
Change in erectile function
time frame: baseline to 6 months
Change in erectile function
time frame: baseline to 12 months
Change in erectile function
time frame: baseline to 24 months
the % of positive margins after resection
time frame: baseline (Day 1)
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
time frame: 1 month
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
time frame: 6 months
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
time frame: 12 months
presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)
time frame: 24 months
Change in function as estimated by the PR25 questionnaire
time frame: baseline to 1 month
Change in function as estimated by the PR25 questionnaire
time frame: baseline to 6 months
Change in function as estimated by the PR25 questionnaire
time frame: baseline to 12 months
Change in function as estimated by the PR25 questionnaire
time frame: baseline to 24 months
Change in quality of life as estimated by the QLQC-30 questionnaire
time frame: baseline to 1 month
Change in quality of life as estimated by the QLQC-30 questionnaire
time frame: baseline to 6 months
Change in quality of life as estimated by the QLQC-30 questionnaire
time frame: baseline to 12 months
Change in quality of life as estimated by the QLQC-30 questionnaire
time frame: baseline to 24 months
Presence/absence of complications (Clavien)
time frame: 1 month
Presence/absence of complications (Clavien)
time frame: 24 months
Presence/absence of complications (Pentafecta)
time frame: 1 month
Presence/absence of complications (Pentafecta)
time frame: 24 months

Eligibility Criteria

Male participants from 45 years up to 75 years old.

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

Additional Information

Official title Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy
Principal investigator Stéphane Droupy, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nīmes.