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.

Endpoints

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 on name to view/download): LAPPRO

Publications:

90-Day readmission after radical prostatectomy-a prospective comparison between robot-assisted and open surgery.
Wallerstedt Lantz A, Stranne J, Tyritzis SI, Bock D, Wallin D, et al.
Scandinavian journal of urology 2019;53(1):26-33.

Agreement between patient reported outcomes and clinical reports after radical prostatectomy - a prospective longitudinal study.
Bock D, Angenete E, Bjartell A, Hugosson J, Steineck G, et al.
Bmc Urology 2019;19(10).

Functional and oncologic outcomes between open and robotic radical prostatectomy at 24-months follow-up in the Swedish LAPPRO trial.
Nyberg M, Hugosson J, Wiklund P, Sjöberg D, Wilderäng U, et al.
European Urology 2018;1(5):353-60.

Health Economic Analysis of Open and Robot-assisted Laparoscopic Surgery for Prostate Cancer Within the Prospective Multicentre LAPPRO Trial.
Forsmark A, Gehrman J, Angenete E, Bjartell A, Bjorholt I, et al.
European Urology 2018;74(6):816-24.

Social constraints and psychological well-being after prostate cancer: A follow-up at 12 and 24 months after surgery.
Stinesen-Kollberg K, Thorsteinsdottir T, Wilderäng U, Hugosson J, Wiklund P, et al.
Psycho-oncology 2018;27(2):668-75.

Thinking about one's own death after prostate-cancer diagnosis.
Thorsteinsdottir TK, Valdimarsdottir H, Stranne J, Wilderäng U, Haglind E, et al.
Supportive care in cancer 2018;26(5):1665-73.

Care-related predictors for negative intrusive thoughts after prostate cancer diagnosisdata from the prospective LAPPRO trial.
Thorsteinsdottir T, Valdimarsdottir H, Hauksdottir A, Stranne J, Wilderäng U, et al.
Psycho-Oncology 2017;26(11):1749-57.

Habits and self-assessed quality of life, negative intrusive thoughts and depressed mood in patients with prostate cancer: a longitudinal study.
Bock D, Angenete E, Bjartell A, Carlsson S, Steineck S, Stranne J, Thorsteinsdottir T, Wiklund P,  Haglind E.
Scand J Urology 2017;51(5):353-9.

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.
Stinesen Kollberg K, Wilderäng U, Thorsteinsdottir T, Hugosson J, Wiklund P, Bjartell A, Carlsson S, Stranne J, Haglind E, Steineck G.
Acta Oncologica 2017;56(7):984-90.

Care-related predictors for negative intrusive thoughts after prostate cancer diagnosis – Data from the prospective LAPPRO trial.
Thorsteinsdottir T, Valdimarsdottir H, Hauksdottir A, Stranne J, Wilderäng U, Haglind E, Steineck G.
Psycho-Oncology 2016;26(11).

Oncologic and functional outcomes one year after radical prostatectomy for very low risk prostate cancer. Results from the prospective LAPPRO trial.
Carlsson S, Jäderling F, Wallerstedt A, Nyberg T, Stranne J, Thorsteinsdottir T, Carlsson SV, Bjartell A, Hugosson J, Haglind E, Steineck G.
BJU Int 2016;118:205-12.

Preparedness for side effects and bother in symptomatic men after radical prostatectomy in a prospective, non-randomized trial, LAPPRO.
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.
Acta Oncol 2016;55(12):1467-76.

Psychological well-being and private and professional psychosocial support after prostate cancer surgery: a follow-up at 3, 12, and 24 months after surgery.
Stinesen Kollberg K, Wilderäng U, Thorsteinsdottir T, Hugosson J, Wiklund P, Bjartell A, Carlsson S, Stranne J, Haglind E, Steineck G.
EurUrol Focus 2016;2(4):418-25.

Degree of Preservation of the Neurovascular Bundles During Radical Prostatectomy and Urinary Continence One Year after Surgery.
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.
Eur Urol 2015;67:559-568.

Short-Term Results after Two Types of Radical Prostatectomy.
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.
EurUrol 2015;67(4):660-70.

Thromboembolic Complications in 3,544 Patients Undergoing Radical Prostatectomy with or without Lymph Node Dissection.
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.
J Urology 2015;193:117-125.

Urinary Incontinence and Erectile Dysfunction After Robotic Versus Open Radical Prostatectomy: A Prospective, Controlled, Nonrandomised Trial.
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.
EurUrol 2015;68(2):216-25.

Interobserver variability in the pathological assessment of radical prostatectomy specimens: findings of the Laparoscopic Prostatectomy Robot Open (LAPPRO) study.
Persson J, Wilderang U, Jiborn T, Wiklund PN, Damber JE, Hugosson J, et al.
Scand J Urol 2014;48:160-7.

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

Patient and tumour-related factors for prediction of urinary incontinence after radical prostatectomy.
Wallerstedt A, Carlsson S, Steineck G, Thorsteinsdottir T, Hugosson J, Stranne J, et al.
Scand J Urol 2013;47:272-8.1.

LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer.
Thorsteinsdottir T, Stranne J, Carlsson S, Anderberg B, Bjorholt I, Damber JE, et al.
Scand J Urol Nephrol 2011;45(2):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)