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NCT Number: NCT02784314

Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

In this observational cost efficacy study, the investigator compare the Laparoscopic Radical Prostatectomy (LRP) versus Robotic-Assisted Laparoscopic Prostatectomy (RALP). Every cost of care that include hospitalization related or post operative medical consumption are obtained and recorded up to 5 years follow up. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Carcinologic results are estimated by Prostate Specific Antigen (PSA) relapse and salvage treatments. Economic evaluation will be made to estimate direct costs of the four postoperative year along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment (preserved urinary continence and erectile function and PSA < 0.2).

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Key information

Conditions

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

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Urologie - Clinique St Augustin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Localized prostate cancer
  • Gleason grade ≤ 3 + 4
  • PSA < 15 ng / mL
  • Stage ≤ T2b
  • Eligible to receive laparoscopic radical prostatectomy
  • Candidate bilateral or unilateral erectile preservation

Exclusion criteria

  • Patient at high risk of postoperative progression (PSA> 15 ng / mL; grade 5 predominant, clinical or radiological stage T3
  • Presenting erectile dysfunction (IIEF < 22)
  • Past history of urinary incontinence (> grade 1 WHO)
  • Body mass index > 30

Treatment and study plan

Robotic-Assisted Radical Prostatectomy

Procedure

Laparoscopic Radical Prostatectomy

Procedure

Primary outcomes

  1. Erectile function

    Time frame: 12 months after surgery

    Proportion of patients with recovery of erectile function between T0 (before surgery) and 12 months after surgery. Recovery is defined as a maximum decrease of 5 points score of the International Index of Erectile Function (IIEF) between pre and postoperative evaluations.

Secondary outcomes

  1. Surgical margins

    Time frame: During surgery

  2. Prostate Specific Antigen (PSA)

    Time frame: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery

  3. Continence

    Time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery

    Continence is assessed by the International Prostate Symptom Score (IPSS)

  4. Tolerance

    Time frame: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery

    Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery

  5. Quality of life

    Time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery

    Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores

  6. Incremental cost-effectiveness ratio

    Time frame: 60 months afet surgery

    Economic evaluation will be made to estimate direct costs of the five postoperative years along with the incremental cost-effectiveness ratio (ICER) per successful surgical treatment

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy

Acronym: ROBOTCAP

Important dates

Study start
2010
Primary completion
2013
Study completion
2016
First posted
May 27, 2016
Registry last updated
Jun 5, 2017

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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