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:

Thorsteinsdottir T, Stranne J,  Carlsson S, Anderberg B, Björholt I, Damber JE, Hugosson J, Wilderäng U, Wiklund P, Steineck G and Haglind E. LAPPRO: A prospective multi-centre comparative study of robot-assisted laparoscopic and retro-pubic radical prostatectomy for prostate cancer. Scand J Urol Nephrol 2011;45:102-112.

Wallerstedt A, Carlsson S, Steineck G, Thorsteinsdottir T, Hugosson J, StranneJ , Wilderäng U, Haglind E, Wiklund NP. Patient and tumour-related factors for prediction of urinary incontinence after radical prostatectomy. Scand J Urol. 2013;47:272-81

Thorsteinsdottir T, Hedelin M, Stranne J, Valdimarsdóttir H, Wilderäng U, Haglind E, Steineck G. Intrusive Thoughts and Quality of Life in Men with Localized Prostate Cancer before and Three Months after Surgery – Data from the Prospective LAPPRO Trial. Health Qual Life Outcomes 2013;11:154-

Persson J, Wilderäng U, Jiborn T, Wiklund P,  Damber JE, Hugosson J, Steineck G, Haglind E, Bjartell A. Interobserver Variability in the Pathological Assessment of Radical Prostatectomy Specimens: Findings of LAPPRO Study. Scand J Urol 2014; 48(2):160-7

Wallerstedt A, Tyritzis SI, Thorsteinsdottir T, Carlsson S, Stranne J, Gustafsson O, Hugosson J, Bjartell A, Wilderäng U, Wiklund P, Steineck G, Haglind E on behalf of the LAPPRO steering committee. Short-Term Results after Two Types of Radical Prostatectomy. EurUrol 2015; 67(4):660-70.

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

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.

Haglind E, Carlsson S, StranneJ, 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.  

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 Aug;118(2):205-12.doi: 10.1111/bju.13444.

Derogar M, Dahlstrand H, Carlsson S, Bjartell A, Hugosson J, Axén E, Johansson E, Lagerkvist M, Nyberg T, Stranne J, Thorsteinsdottir T, Wallerstedt A, Haglind E, Wiklund P, Steineck G; LAPPRO steering committee. Preparedness for side effects and bother in symptomatic men after radical prostatectomy in a prospective, non-randomized trial, LAPPRO. Acta Oncol. 2016 Dec;55(12):1467-1476.

Thorsteinsdottir T, Valdimarsdottir H, Hauksdottir A, Stranne J, Wilderäng U, Haglind E, Steineck G. Care-related predictors for negative intrusive thoughts after prostate cancer diagnosis – Data from the prospective LAPPRO trial. Accepted Psycho-Oncology dec 2016. DOI: 10.1002/pon.4359

Stinesen Kollberg K, Wilderäng U, Thorsteinsdottir T, Hugosson J, Wiklund P, Bjartell A, Carlsson S, Stranne J, Haglind E, Steineck G. How badly did it hit? Self-assessed emotional shock upon prostate cancer diagnosis and psychological well-being: a follow-up at 3, 12, and 24 months after surgery. Acta Oncologica, accepted 2017

Bock D, Angenete E, Bjartell A, Carlsson S, Steineck S, Stranne J, Thorsteinsdottir T, Wiklund P,  Haglind E. Lifestyle and self-assessed quality of life, negative intrusive thoughts and depressed mood in patients with prostate cancer – a longitudinal study. Scand J Urology accepted May 2017

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)