Prostate cancer screening – ready for primetime?

Abstract The European Council 2022 cancer screening recommendations address prostate cancer screening, and I will here examine the guidance and its implications. The recommendation reads as “countries should consider a stepwise approach to evaluate the feasibility and effectiveness of the implementation of organised programmes”. It states that novel screening tests should be introduced only after they have been evaluated in randomised trials with conclusive evidence. Furthermore, level of evidence should be assessed by pooling trial results. Outcomes listed include mortality, cost-effectiveness, and quality of life. Further, all of Wilson and Jungner criteria and the additional WHO criteria should be assessed. What is then the current evidence of prostate cancer screening? Systematic reviews of PSA-based screening have concluded that the pooled results from the ERSPC, PLCO and CaP trial do not show a clear mortality benefit, even though the largest ERSPC trial does. The main adverse outcome of PSA-based screening has been overdiagnosis, with 31 excess cases per 1000 men at 19 years in the ERSPC. Screening utilising MRI is being examined in several trials (Göteborg2, Sthlm3-MRI and ProScreen) with early results providing evidence for less overdiagnosis than seen in PSA-based screening. However, no mortality results have been published and only one trial is aimed at evaluating mortality impact. Based on the current evidence, it would be hard to claim that the evidence requirements by the EC are met, especially those regarding mortality. On the other hand, the recommendation also mentions that for new modifications of existing tests, validated surrogate endpoints would suffice. Can we then infer that the mortality benefit in ERSPC trial is applicable to screening with MRI? And rely on modelling studies of cost-effectiveness? In my view, solid empirical data are needed for making a decision that will affect the nearly 200 million European men aged 50-69 years.