Clinical trial NCT02784314: Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy
Official title: Medico-economic Evaluation of Robotic-assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Clinically localized prostate cancer
Robotic-assisted prostatectomy
Laparoscopic prostatectomy
Erectile function ;
Cost efficacy study
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 25
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Erectile function
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Surgical margins
timeFrame: During surgery
measure: Prostate Specific Antigen (PSA)
timeFrame: Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
measure: Continence
timeFrame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
measure: Tolerance
timeFrame: Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
measure: Quality of life
timeFrame: Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
measure: Incremental cost-effectiveness ratio
timeFrame: 60 months afet surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service d'Urologie - Clinique St Augustin
city: Lyon cedex 03
country: France
facility: Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon
city: Paris
country: France
facility: Service d'Urologie - Institut Mutualiste Montsouris
Study officials:
References: