Overview of Performance Indicators of Prostate Cancer Screening Trials.

Background and objective: Prostate cancer (PCa) screening is highly debated in urological literature and in the society. In 2021, the EU Commission proposed pilot studies to explore the feasibility of risk-based population-based PCa screening. The PRostate cancer Awareness and Initiative for Screening in the European Union (PRAISE-U) project aims to evaluate the feasibility and effectiveness of screening pilots by applying specific performance indicators (PIs). A comparison of the PIs of new screening initiatives with those of previous trials can provide valuable insights. This study offers an overview of the data from the largest ongoing and past PCa screening trials, translating these into uniformly calculated PIs to serve as a reference for future studies. Methods: A narrative review was conducted. Population-based screening trials with ≥1000 participants were included. The following main indicators were extracted and presented: participation rate, proportion of screening positives, applied risk stratification tools, proportion of magnetic resonance imaging (MRI) scans and MRI compliance, proportion of biopsies and biopsy compliance, cancer detection rates, and proportion of clinically significant PCa cases. Key findings and limitations: Ten trials were included for analysis (European Randomised Study of Screening for Prostate Cancer; Cluster randomised trial of prostate-specific antigen (PSA) testing for Prostate cancer; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial; Prostate Cancer Early Detection Study Based on a "Baseline" PSA value in Young Men; Göteborg-2; Early Prostate Cancer Detection Programme; Organised Prostate cancer Testing; STHLM3-MRI; ProScreen; and BARCODE1). Participation rates varied widely (from 12% to 89%), affected largely by study start year (associated with opportunistic PSA testing), study design, and age of participants. PSA positivity rates ranged from 0.8% to 29%, associated mainly with age, usage of repeat PSA tests, and socioeconomic factors. The proportion of MRI scans among participants ranged from 0.6% to 11%, dependent mainly on indication, number of positive multivariable algorithms, and age. Biopsy rates among participants ranged from 0.5% to 25%, affected by risk stratification strategies, compliance, and biopsy trigger. The detection rate of clinically significant PCa, calculated as the proportion of any PCa cases, ranged from 41% to 82%. Conclusions and clinical implications: The PIs presented here may serve as a reference for other ongoing national screening pilot studies such as PRAISE-U. Differences in time period, population, informed consent strategy, and diagnostic algorithm lead to a wide range of PIs. These factors must be considered and taken into account to correctly compare the PIs across different national screening pilots. Patient summary: The effectiveness of a screening program can be assessed using performance indicators. In this article, we present a comprehensive overview of the performance indicators for the most well-known prostate cancer (PCa) screening studies. This can serve as a reference for ongoing and future PCa screening initiatives. However, it is important to consider that several factors, such as differences in target population, protocols, and diagnostic algorithms may affect outcomes when comparing these studies.