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Completed

NCT Number: NCT01577836

Medico-economic Comparison of Robot-assisted Radical Prostatectomy 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).

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Key information

Conditions

Prostatic Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Urogenital Diseases Urogenital Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

APHM - Hôpital de la Conception, Marseille, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-Assisted Radical Prostatectomy

Procedure

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

Radical prostatectomy via laparotomy

Procedure

Classic radical prostatectomy via open retropubic approach

Primary outcomes

  1. 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.

Secondary outcomes

  1. Cost (€) of surgery via micro-costing

    Time frame: Day 1

    All human and material resources necessary for carrying out a prostatectomy will be evaluated.

  2. Change in erectile function

    Time frame: baseline to 1 month

    the International Index of Erectile Function (IIEF-15) will be used.

  3. Change in erectile function

    Time frame: baseline to 6 months

    the International Index of Erectile Function (IIEF-15) will be used.

  4. Change in erectile function

    Time frame: baseline to 12 months

    the International Index of Erectile Function (IIEF-15) will be used.

  5. Change in erectile function

    Time frame: baseline to 24 months

    the International Index of Erectile Function (IIEF-15) will be used.

  6. the % of positive margins after resection

    Time frame: baseline (Day 1)

  7. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)

    Time frame: 1 month

  8. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)

    Time frame: 6 months

  9. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)

    Time frame: 12 months

  10. presence/absence of PSA (Prostate Specific Antigen ) > 0.2 ng/ml (recurrence)

    Time frame: 24 months

  11. Change in function as estimated by the PR25 questionnaire

    Time frame: baseline to 1 month

  12. Change in function as estimated by the PR25 questionnaire

    Time frame: baseline to 6 months

  13. Change in function as estimated by the PR25 questionnaire

    Time frame: baseline to 12 months

  14. Change in function as estimated by the PR25 questionnaire

    Time frame: baseline to 24 months

  15. Change in quality of life as estimated by the QLQC-30 questionnaire

    Time frame: baseline to 1 month

  16. Change in quality of life as estimated by the QLQC-30 questionnaire

    Time frame: baseline to 6 months

  17. Change in quality of life as estimated by the QLQC-30 questionnaire

    Time frame: baseline to 12 months

  18. Change in quality of life as estimated by the QLQC-30 questionnaire

    Time frame: baseline to 24 months

  19. 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.)

  20. 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.)

  21. Presence/absence of complications (Pentafecta)

    Time frame: 1 month

    The Pentafecta classification will be used.

  22. Presence/absence of complications (Pentafecta)

    Time frame: 24 months

    The Pentafecta classification will be used.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: RoboProstate

Important dates

Study start
2012
Primary completion
2018
Study completion
2021
First posted
Apr 16, 2012
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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