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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01577836
First received: April 13, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition
Prostatic Neoplasms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Medico-economic Comparison of Robot-assisted Radical Prostatectomy Using the da Vinci System Versus Radical Prostatectomy Via Laparotomy

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Overall cost (€) of patient care [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Cost of surgical treatment of localized prostate cancer by radical prostatectomy (robot-assisted or conventional retropubic laparotomy) and its follow-up for 2 years. All medical resources consumed will be evaluated during the first 2 years after surgery.


Secondary Outcome Measures:
  • Cost (€) of surgery via micro-costing [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    All human and material resources necessary for carrying out a prostatectomy will be evaluated.

  • Change in erectile function [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
    the International Index of Erectile Function (IIEF-15) will be used.

  • Change in erectile function [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
    the International Index of Erectile Function (IIEF-15) will be used.

  • Change in erectile function [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    the International Index of Erectile Function (IIEF-15) will be used.

  • Change in erectile function [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
    the International Index of Erectile Function (IIEF-15) will be used.

  • the % of positive margins after resection [ Time Frame: baseline (Day 1) ] [ Designated as safety issue: Yes ]
  • presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
  • Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in function as estimated by the PR25 questionnaire [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 1 month ] [ Designated as safety issue: No ]
  • Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
  • Change in quality of life as estimated by the QLQC-30 questionnaire [ Time Frame: baseline to 24 months ] [ Designated as safety issue: No ]
  • Presence/absence of complications (Clavien) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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.)

  • Presence/absence of complications (Clavien) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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.)

  • Presence/absence of complications (Pentafecta) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    The Pentafecta classification will be used.

  • Presence/absence of complications (Pentafecta) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    The Pentafecta classification will be used.


Estimated Enrollment: 90
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Robotic assistance, Nîmes
The patients in this group will undergo robot-assisted radial prostatectomy at the University Hospital of Nîmes.
Laparotomy, Marseilles
The patients in this group will undergo radical prostatectomy via traditional laparotomy at the University Hospital Marseillles.

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.
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577836

Contacts
Contact: Stéphane Droupy, MD PhD +33.(0)4.66.68.37.17 stephane.droupy@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
APHM - Hôpital de la Conception Recruiting
Marseille Cedex 5, France, 13385
Sub-Investigator: Eric Lechevallier, MD PhD         
Clinique Beau Soleil Not yet recruiting
Montpellier, France, 34070
Sub-Investigator: Xavier Rebillard, MD         
CHU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 09, France, 30029
Principal Investigator: Stephane Droupy, MD PhD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Stéphane Droupy, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01577836     History of Changes
Other Study ID Numbers: AOI/2011/SD-03, 2011-A01385-36
Study First Received: April 13, 2012
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Radical prostatectomie
Robotic assistance
Laparotomy

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014