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Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy (ROBOTCAP)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robotic-Assisted Radical Prostatectomy
Laparoscopic Radical Prostatectomy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Clinically localized prostate cancer, Robotic-assisted prostatectomy, Laparoscopic prostatectomy, Erectile function ;, Cost efficacy study

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Service d'Urologie - Clinique St Augustin
  • Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon
  • Service d'Urologie - Institut Mutualiste Montsouris

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic-Assisted Radical Prostatectomy

Laparoscopic Radical Prostatectomy

Arm Description

Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System

Standard laparoscopic Radical Prostatectomy

Outcomes

Primary Outcome Measures

Erectile function
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 Outcome Measures

Surgical margins
Prostate Specific Antigen (PSA)
Continence
Continence is assessed by the International Prostate Symptom Score (IPSS)
Tolerance
Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery
Quality of life
Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores
Incremental cost-effectiveness ratio
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

Full Information

First Posted
May 20, 2016
Last Updated
June 2, 2017
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT02784314
Brief Title
Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy
Acronym
ROBOTCAP
Official Title
Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Clinically localized prostate cancer, Robotic-assisted prostatectomy, Laparoscopic prostatectomy, Erectile function ;, Cost efficacy study

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic-Assisted Radical Prostatectomy
Arm Type
Experimental
Arm Description
Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System
Arm Title
Laparoscopic Radical Prostatectomy
Arm Type
Active Comparator
Arm Description
Standard laparoscopic Radical Prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Robotic-Assisted Radical Prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Radical Prostatectomy
Primary Outcome Measure Information:
Title
Erectile function
Description
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.
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Surgical margins
Time Frame
During surgery
Title
Prostate Specific Antigen (PSA)
Time Frame
Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Title
Continence
Description
Continence is assessed by the International Prostate Symptom Score (IPSS)
Time Frame
Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Title
Tolerance
Description
Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery
Time Frame
Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
Title
Quality of life
Description
Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores
Time Frame
Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
Title
Incremental cost-effectiveness ratio
Description
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
Time Frame
60 months afet surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service d'Urologie - Clinique St Augustin
City
Bordeaux
ZIP/Postal Code
33074
Country
France
Facility Name
Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon
City
Lyon cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Service d'Urologie - Institut Mutualiste Montsouris
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

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