Abstract
Objectives
To assess the effects of prostate cancer screening compared to no screening in men with no prior diagnosis of prostate cancer.
Methods
This systematic review represents an update of a prior Cochrane review from 2013, searching multiple databases up to November 2025. We included randomised controlled trials (RCTs) of prostate cancer screening vs no screening. We used standard Cochrane methods, including rating the certainty of the evidence following a Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.
Results
Six RCTs (789 086 participants; follow‐up 3.2–23 years) were included: five evaluated prostate‐specific antigen (PSA)‐alone screening; one evaluated PSA combined with a kallikrein panel and magnetic resonance imaging (MRI) (ProScreen). Results are based on the certainty of evidence for each outcome and are therefore mainly derived from a sensitivity analysis by risk of bias, using the European Randomised Study of Screening for Prostate Cancer (ERSPC) trial: screening likely results in a reduction in prostate cancer‐specific mortality (sensitivity analysis from ERSPC: risk ratio [RR] 0.87, 95% confidence interval [CI] 0.80–0.95; one study, 162 236 participants; moderate‐certainty evidence; minimal clinically important difference [MCID]: one per 1000 participants). Assuming a baseline risk of 16 prostate‐cancer‐related deaths per 1000, this corresponds to two fewer (95% CI three fewer to one fewer) per 1000. Based on the analysis that included all eligible trials, screening may reduce overall mortality, although the CI includes the possibility of little to no effect (RR 0.99, 95% CI 0.97–1.00;
I
2
= 22%; four studies, 675 121 participants; low‐certainty evidence; MCID: one per 1000 participants). Assuming a baseline risk of 491 deaths from any cause per 1000, this corresponds to five fewer (95% CI 15 fewer to 0 fewer) per 1000. Screening may result in little to no difference in adverse events (RR 1.32, 95% CI 0.48–3.65; low certainty) or quality of life. In the ProScreen trial (60 745 participants, 3.2‐year follow‐up), combined screening probably has little to no effect on overall detection (RR 1.85, 95% CI 1.56–2.19; moderate certainty), localised detection (RR 1.88, 95% CI 1.55–2.27; moderate certainty), or advanced detection (RR 1.78, 95% CI 1.19–2.66; moderate certainty). Mortality data are not yet mature.
Conclusions
Screening likely reduces prostate cancer‐specific mortality and may reduce overall mortality. It may have little to no effect on adverse events (as measured by intervention‐related mortality). Study limitations, inconsistency, and imprecision reduced our confidence in the effect estimates. Interpretation of these findings is highly sensitive to the choice of MCID. Emerging alternatives, such as screening with a kallikrein panel and MRI, may have little to no effect on diagnoses of prostate cancer, but the results on mortality are not yet known.