Economic Evaluation of Robot-assisted Laparoscopic Radical Prostatectomy vs Conventional Laparoscopic Radical Prostatectomy and Open Retropubic Radical Prostatectomy in Prostate Cancer: a Real-life Study Based on the French National Healthcare Data System (SNDS)

NCT04587284 | Unknown

• 1 other identifier: CHUBX 2018/72
• Study Type: observational
• Target: 84,667
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Incremental cost / progression-free (without additional treatment) life-year saved 5 years after initial surgery

  Progression-free survival requiring new treatment at 5 years will be calculated from : * Death within 5 years of surgery * Occurrence, over the period (5 years), of recurrences / progressions requiring additional treatment by radiotherapy and / or hormone therapy. A sensitivity analysis will be carried out after 1: 1 matching between subjects in each prostatectomy group. Estimation of the probability of event-free survival using the Kaplan-Meier estimator; Comparison of the risk of occurrence of each event between groups using a Cox proportional hazards model (after checking the underlying assumptions). The risk comparison will be measured using an hazard ratio, its 95% confidence interval and the p-value associated with the Wald test * without adjustment, from the overall population; * after adjustment for the propensity score, from the overall population; * from matched groups 1: 1.

  5 years after initial surgery

Secondary Outcomes (1)

• Incremental cost / life-year saved at 8 years.

  8 years after initial surgery

Other Outcomes (2)

• Cost of robotic surgery.

  5 years after initial surgery;8 years after initial surgery

• Urological hospitalizations within 90 days following the initial surgery.

  90 days following the initial surgery

Study Arms (3)

Patients with robot-assisted laparoscopic radical prostatectomy

Patients with open retropubic radical prostatectomy

Patients with laparoscopic radical prostatectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three groups will be constituted according to surgical procedure: robot-assisted laparoscopic radical prostatectomy, open retropubic radical prostatectomy, and laparoscopic radical prostatectomy. All patients will be followed for at least 5 years and up to 8 years from the index date. Index date will be defined as the initial radical prostatectomy surgery performed between 2012-2015.

You may qualify if:

• Total retro-pubic prostatectomy (PTRP) identified in the SNDS by the standard, Classification of Medical Acts "JGFA006" act
• Laparoscopic total prostatectomy (PTL) identified in the SNDS by the CCAM "JGFC001" act and the health and social establishment files number of centers not equipped with a surgical robot
• Robot-assisted total prostatectomy (PTRA) identified in the SNDS by the CCAM "JGFC001" act and the health and social establishment files number of centers equipped with a surgical robot for more than 12 months and having a rate of use of this technique for more than 95% minimally invasive prostatectomies. The number of PTRA will be identified by a survey in each center and the manufacturer's data as explained above
• Patient who has not received previous treatment for this cancer by hormone therapy, radiotherapy, brachytherapy or HiFU (treatments sought in the SNDS prior to surgery by the prescription of pharmaceutical specialties or the presence of CCAM procedures)

You may not qualify if:

• Patient operated for laparoscopic radical prostatectomy or robot-assisted laparoscopic radical prostatectomy in a center equipped with a surgical robot but with a rate of use of this technique less than 95% (centers offering different minimally invasive approaches that do not allow to define if the intervention was performed in robotic surgery or in open surgery)
• Patient operated for a robot-assisted laparoscopic radical prostatectomy in a center having started a robotic activity for less than 12 months
• Patient previously treated with another therapeutic modality for his prostate cancer (salvage prostatectomies after hormone therapy, radiotherapy, brachytherapy or HiFU)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Bordeaux PharmacoEpi: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Talence, 33400, France

RECRUITING

Related Publications (1)

• Robert G, Blin P, Bladou F, Jove J, Ouattara E, Rouyer M, Droz-Perroteau C, Piazza L, Preaubert N. Comparative effectiveness of robot-assisted vs. open prostatectomy: a real-life nationwide study. World J Urol. 2025 Jun 10;43(1):367. doi: 10.1007/s00345-025-05715-0.

  PMID: 40493202 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Nathalie PREAUBERT

CONTACT

05 57 82 01 59; nathalie.hayes@chu-bordeaux.fr

Laurent PIAZZA

CONTACT

05 57 82 08 22; laurent.piazza@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: January 1, 2020
• Primary Completion: April 1, 2021
• Study Completion: January 1, 2023
• Last Updated: October 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)