Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

Prostate Cancer Clinical Trial

— ROBOTCAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784314
• Other study ID #: 2009.587
• Status: Completed
• Phase: N/A
• First received: May 20, 2016
• Last updated: June 2, 2017
• Start date: May 2010
• Est. completion date: August 2016

Study information

• Verified date: June 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Robotic-Assisted Radical Prostatectomy

• Laparoscopic Radical Prostatectomy

Locations

Country	Name	City	State
France	Service d'Urologie - Clinique St Augustin	Bordeaux
France	Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot -Hospices Civils de Lyon	Lyon cedex 03
France	Service d'Urologie - Institut Mutualiste Montsouris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after surgery
Secondary	Surgical margins		During surgery
Secondary	Prostate Specific Antigen (PSA)		Before surgery (T0), 6 months (M6), 12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Secondary	Continence	Continence is assessed by the International Prostate Symptom Score (IPSS)	Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12), 24 months (M24) and 60 months (M60) after surgery
Secondary	Tolerance	Adverse events related to the perioperative prostatectomy, 6 months, 12 months and 24 months afer surgery	Perioperative period, 6 months (M6), 12 months (M12) and 24 months (M24) afer surgery
Secondary	Quality of life	Quality of life is assessed by EQ-5D, QLQ-C30 and QLQ-PR25 scores	Before surgery (T0), 6 months (M6), 9 months (M9),12 months (M12) and 24 months (M24) after surgery
Secondary	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	60 months afet surgery