LAPPRO: A prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer

Abstract

Objective. This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. Material and methods. The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. Results. The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. Conclusions. The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.

Key Words::

• Clinical trial
• retropubic radical prostatectomy
• robot-assisted laparoscopic radical prostatectomy
• prostate neoplasm
• study design
• urological surgical procedures

Acknowledgements

The authors are grateful to the members of the LAPPRO steering committee and local investigators at the participating urology departments: Anders Bjartell, Malmö University Hospital; Ola Bratt, Helsingborg Hospital; Hans Boman, Alingsås Hospital; Christer Edlund, Kungsbacka Hospital; Sven Grundtman, Uddevalla Hospital; Ove Gustafsson, Karolinska University Hospital/Huddinge; Thomas Jiborn, Malmö University Hospital; Ingrid Höglund Karlsson, Sahlgrenska University Hospital; Ali Khatami, Sahlgrenska University Hospital; Mikael Lagerkvist, UroClinic Stockholm; Eric Pileblad, Capio Lundby Hospital; Mikael Sylme, Varberg Hospital; and Ulrika Westlund, Södersjukhuset. The authors are also grateful to the personnel at the LAPPRO trial secretariat and the regional tumour registry and oncologic centre, Sahlgrenska University Hospital, for their essential input into the study procedure. Torgny Anderson at Interezza developed and supported technically the management of the patient-contact database. The trial is supported by grants from the Swedish Cancer Foundation, the West Gothia Region, Sahlgrenska University Hospital, Sanofi-Aventis and Mary von Sydow Foundation.

Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.