Prostate cancer (PCa) is a major public health concern for men globally and the most commonly diagnosed cancer among men in the European Union (EU). Despite large trials suggesting benefits from early detection of PCa, risks of overdiagnosis and overtreatment are evident. In 2022, the EU Commission proposed introducing prostate-specific antigen (PSA) testing for men in an organised setting, in combination with magnetic resonance imaging (MRI) scanning as a follow-up test to minimise these risks. PRostate cancer Awareness and Initiative for Screening Europe (PRAISE-U) is a pilot study evaluating the implementation of a risk-stratified population-based approach to PCa screening in Ireland, Lithuania, Poland, and two areas in Spain (Galicia and Manresa) for feasibility, efficacy, and cost effectiveness. As per the protocol designed for the pilots, men aged 50-69 yr residing within the catchment area of the study sites will be invited to participate. Those consenting to participate will undergo PSA testing, and men with PSA >3 ng/ml will undergo risk stratification before MRI and, if necessary, after MRI before undergoing biopsy. A collaborative user board comprising health care professionals, patients, and decision-makers will be formed to provide stakeholder input throughout the study. PRAISE-U will be evaluated on three major pillars: analysis of clinical and programme outcomes, psychosocial impact, and cost effectiveness. A set of key performance indicators (KPIs) has been developed to be piloted in the PRAISE-U pilot sites. The KPIs will serve to assess the performance and outcomes of risk-stratified PCa screening at each site. A REDCap database will be used to collect and manage pseudoanonymised data from the pilot sites. Ethics approval was obtained from each pilot site. The PRAISE-U pilot implementation is expected to commence in the 3rd quarter of 2024 for 12 mo and provide valuable data on the implementation outcomes of a risk-stratified screening approach across Europe. The findings is expected to inform the development of an optimised screening strategy with an acceptable benefit to harm ratio.
European urology open science. 2024 Oct 11*** epublish ***
Arunah Chandran, Meike van Harten, Deependra Singh, Josep Vilaseca, Ausvydas Patasius, Krzysztof Tupikowski, Ángel Gómez Amorín, David Galvin, Héctor López, Juan Pablo Salazar, Anna Arnau, Gemma Cuberas, Gintare Miksiene, Katarzyna Hodyra-Stefaniak, Monika Litwin, Małgorzata Krynicka-Duszyńska, Paweł Zawadzki, Adam Maciejczyk, Gillian Horgan, Pieter Vynckier, Lieven Annemans, Milagros Otero-Garcia, Pia Kirkegaard, Mette Bach Larsen, Sofie Meyer Andersen, Grace McKinney, Vera Vasilyeva, Peter-Paul Willemse, Roderick van den Bergh, Lionne D F Venderbos, Sarah Collen, Hendrik van Poppel, Monique J Roobol, Partha Basu, PRAISE-U Consortium
International Agency for Research on Cancer, Lyon, France., Department of Urology, Utrecht University Medical Center, Utrecht, The Netherlands., Althaia, Xarxa Assistencial Universitària de Manresa, Manresa, Spain., Faculty of Medicine, Institute of Clinical Medicine, Vilnius, Lithuania., Lower Silesian Center for Oncology, Pulmonology and Hematology, Wrocław, Poland., Service for Population Screening Programs, Ministry of Health, San Lázaro, Spain., University College Dublin, Dublin, Ireland., Ghent University, Ghent, Belgium., Radiology Department, Hospital Álvaro Cunqueiro, Vigo, Spain., University Research Clinic for Cancer Screening, Department of Public Health Programmes, Randers Regional Hospital, Randers, Denmark., European Association of Urology, Arnhem, The Netherlands., Department of Urology, Erasmus MC Cancer Institute, University Medical Center, Rotterdam, The Netherlands.