Chandran Arunah, van Harten Meike, Singh Deependra, Vilaseca Josep, Patasius Ausvydas, Tupikowski Krzysztof, Amorín Ángel Gómez, Galvin David, López Héctor, Salazar Juan Pablo, Arnau Anna, Cuberas Gemma, Miksiene Gintare, Hodyra-Stefaniak Katarzyna, Litwin Monika, Krynicka-Duszyńska Małgorzata, Zawadzki Paweł, Maciejczyk Adam, Horgan Gillian, Vynckier Pieter, Annemans Lieven, Otero-Garcia Milagros, Kirkegaard Pia, Larsen Mette Bach, Andersen Sofie Meyer, McKinney Grace, Vasilyeva Vera, Willemse Peter-Paul, van den Bergh Roderick, Venderbos Lionne D F, Collen Sarah, van Poppel Hendrik, Roobol Monique J, Basu Partha
International Agency for Research on Cancer, Lyon, France.
Department of Urology, Utrecht University Medical Center, Utrecht, The Netherlands.
Eur Urol Open Sci. 2024 Oct 11;70:8-17. doi: 10.1016/j.euros.2024.09.003. eCollection 2024 Dec.
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.
前列腺癌（PCa）是全球男性主要的公共卫生问题，也是欧盟（EU）男性中最常被诊断出的癌症。尽管大型试验表明早期检测前列腺癌有益，但过度诊断和过度治疗的风险也很明显。2022年，欧盟委员会提议在有组织的环境中对男性进行前列腺特异性抗原（PSA）检测，并结合磁共振成像（MRI）扫描作为后续检测，以尽量减少这些风险。欧洲前列腺癌筛查意识与倡议（PRAISE-U）是一项试点研究，评估在爱尔兰、立陶宛、波兰以及西班牙的两个地区（加利西亚和曼雷萨）实施基于风险分层的人群前列腺癌筛查方法的可行性、有效性和成本效益。根据为试点设计的方案，居住在研究地点集水区内年龄在50至69岁的男性将被邀请参与。同意参与的人将接受PSA检测，PSA>3 ng/ml的男性在MRI检查前以及必要时在MRI检查后活检前将进行风险分层。将组建一个由医疗保健专业人员、患者和决策者组成的协作用户委员会，在整个研究过程中提供利益相关者的意见。PRAISE-U将在三个主要方面进行评估：临床和项目结果分析、心理社会影响以及成本效益。已经制定了一套关键绩效指标（KPI），将在PRAISE-U试点地点进行试点。这些KPI将用于评估每个地点风险分层前列腺癌筛查的绩效和结果。将使用REDCap数据库收集和管理来自试点地点的伪匿名数据。每个试点地点均已获得伦理批准。PRAISE-U试点实施预计将于2024年第三季度开始，为期12个月，并将提供有关欧洲风险分层筛查方法实施结果的宝贵数据。预计这些结果将为制定具有可接受的利弊比的优化筛查策略提供参考。
