Robotic surgery for prostate cancer, LAParoscopic Prostatectomy Robot or Open- LAPPRO

 

The study is a national, prospective, non-randomized multicentre trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy in terms of functional and oncological outcome. Twelve Departments of Urology in Sweden have included patients consecutively. Five of these departments perform radical prostatectomy by robot-assisted technique and seven by open surgery. The intention of the LAPPRO-trial is to compare the two surgical techniques in aspects of short-and long-term functional and oncological outcome, cost-effectiveness and quality of life, thus providing new knowledge to support future decisions in treatment strategies for prostate cancer.

Hypotheses

Robot-assisted laparoscopic prostatectomy gives:

-       Less permanent complications after surgery compared to open surgery; primary outcome is urinary incontinence at 12 months

-       Better oncologic result with fewer recurrences with surrogate variables radicality in the pathology report and recurrence by PSA-relapse.

-       Better health related QoL

-       Lower costs for society and health care

 End-points

Primary:

-       Urinary leakage one year after surgery.

Secondary:

-       Erectile dysfunction, Oncological outcome, Quality of life and Health economy

Inclusion

Inclusion criteria:

-       Localized prostate cancer T1-T3

-       PSA≤20

-       Fit for prostatectomy

-       Any Gleason Grade

-       Age≤75

-       Informed consent

-       Read and write Swedish

-       No prior malignancy

-       No distant metastases

Inclusion of patients:

-       Concluded, 4012 patients in total

Participating hospitals

Stockholm: Karolinska University Hospital/Solna, Karolinska University Hospital/Huddinge, Södersjukhuset, Capio St Göran hospital, UroClinic.

Göteborg: Sahlgrenska University Hospital, Carlanderska hospital, Capio Lundby hospital.

Halland: Varberg & Kungsbacka hospitals.

Western Region: NU-sjukvården/Uddevalla hospital, Alingsås hospital.

Skane Region: Malmö University Hospital, Helsingborg hospital.

Funding:

The trial is supported by research grants from The Swedish Research Council, The Swedish Cancer Foundation, ALF agreement (Västra Götaland Region).

Protocol amendment:

The follow-up period has been extended from originally 24 months, to 10 years, with data collection points at 6 years after index surgery through a structured telephone interview and after 8 years through a questionnaire. The 10 year follow up is planned to be through existing national registers.

Documents

Protocol (click name to download): LAPPRO

Publications:

- Stinesen Kollberg K, Wilderäng U, Thorsteinsdottir T, Hugosson J, Wiklund P, Bjartell A, Carlsson S, Stranne J, Haglind E, Steineck G. Psychological wellbeing, private, and professional psychosocial support after prostate cancer surgery: a follow-up at 3, 12, and 24 months after surgery. EurUrol Focus 2016

- Carlsson S, Jäderling F, Wallerstedt A, Nyberg T, Stranne J, Thorsteinsdottir T, Carlsson SV, Bjartell A, Hugosson J, Haglind E, Steineck G. Oncologic and functional outcomes one year after radical prostatectomy for very low risk prostate cancer. Results from the prospective LAPPRO trial. BJU Int. 2016 Feb 11. doi: 10.1111/bju.13444.

- Haglind E, Carlsson S, Stranne J, Wallerstedt A, Wilderäng U, Thorsteinsdottir T,  Lagerkvist M, Wiklund P, Bjartell A, Hugosson J, Damber JE, Steineck G on behalf of the LAPPRO steering committee. Urinary Incontinence after Two Techniques for Performing Radical Prostatectomy. EurUrol 2015;68(2):216-25. 

- Steineck G, Bjartell A,Hugosson J, Axén E, Carlsson S,Stranne J, Wallerstedt A, Persson J, Wilderäng U, Thorsteinsdottir T, Gustafsson O, Lagerkvist M, Jiborn T, Haglind E, Wiklund P on behalf of the LAPPRO steering committee. Degree of Preservation of the Neurovascular Bundles During Radical Prostatectomy and Urinary Continence One Year after Surgery. Eur Urol 2015;67:559-568

- Wallerstedt A, TyritzisSI, ThorsteinsdottirT, CarlssonS, StranneJ, GustafssonO, HugossonJ, BjartellA, WilderängU, WiklundP, SteineckG, Haglind Eon behalf of the LAPPRO steering committee. Short-Term Results after Two Types of Radical Prostatectomy. EurUrol 2015; 67(4):660-70.

- Tyritzis SI, Wallerstedt A, Steineck G, Nyberg T, Hugosson J, Bjartell A,  Wilderäng U, Thorsteinsdottir T, Carlsson S, Stranne J, Haglind E, Wiklund NP on behalf of the LAPPRO steering committee. Lymph node dissection during radical prostatectomy and thromboembolic complications in 3544 patients. J Urology 2015;193:117-125.

- Persson J, Wilderang U, Jiborn T, Wiklund PN, Damber JE, Hugosson J, Steineck G, Haglind E, Bjartell A: Interobserver variability in the pathological assessment of radical prostatectomy specimens: findings of the Laparoscopic Prostatectomy Robot Open (LAPPRO) study. Scand J Urol 2014;48:160-167.

- Wallerstedt A, Carlsson S, Steineck G, Thorsteinsdottir T, Hugosson J, Stranne J, Wilderang U, Haglind E, Wiklund NP: Patient and tumour-related factors for prediction of urinary incontinence after radical prostatectomy. Scand J Urol 2013;47:272-281.

- Thorsteinsdottir T, Hedelin M, Stranne J, Valdimarsdottir H, Wilderang U, Haglind E, Steineck G, Committee LA: Intrusive thoughts and quality of life among men with prostate cancer before and three months after surgery. Health Qual Life Outcomes 2013; 11:154.

- Thorsteinsdottir T, Stranne J, Carlsson S, Anderberg B, Bjorholt I, Damber JE, et al. LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer. Scand J Urol and Nephrol 2011;45:102-12. 

Contact

Principal investigator:

Eva Haglind

Deputy principal investigator:

Gunnar Steineck

Questions:

PI Eva Haglind (eva.haglind@vgregion.se) or research nurse Ingrid Höglund-Karlsson (ingrid.hoglund-karlsson@vgregion.se)