Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments robotic-assisted radical prostatectomy, laparoscopic radical prostatectomy
Sponsor Hospices Civils de Lyon
Start date May 2010
End date May 2013
Trial size 25 participants
Trial identifier NCT02784314, 2009.587

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Robotic-Assisted Radical Prostatectomy using da Vinci Surgical System
robotic-assisted radical prostatectomy
(Active Comparator)
Standard laparoscopic Radical Prostatectomy
laparoscopic radical prostatectomy

Primary Outcomes

Measure
Erectile function
time frame: 12 months after surgery

Secondary Outcomes

Measure
Surgical margins
time frame: During surgery
Prostate Specific Antigen (PSA)
time frame: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Continence
time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Tolerance
time frame: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
Quality of life
time frame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
Incremental cost-effectiveness ratio
time frame: 60 months afet surgery

Eligibility Criteria

Male participants from 40 years up to 70 years old.

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

Additional Information

Official title Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.