European Study of Prostate Cancer Screening — 23-Year Follow-up

BACKGROUND: The European Randomized Study of Screening for Prostate Cancer (ERSPC) was initiated in 1993 to assess the effect of prostate-specific antigen (PSA) testing on prostate cancer mortality. Because deaths from prostate cancer are expected to rise worldwide owing to increased life expectancy and population growth, a final analysis of the long-term outcomes of prostate cancer screening is essential to understanding the benefits and harms of PSA testing. METHODS: We updated the findings from ERSPC, a multicenter, randomized study conducted across eight European countries with a focus on a predefined core age group of 162,236 men who were 55 to 69 years of age at the time of randomization. Participants were randomly assigned to the screening group and offered repeated PSA testing or to the control group and not invited for screening. The primary outcome was prostate cancer mortality. RESULTS: After a median follow-up of 23 years, prostate cancer mortality was 13% lower in the screening group (rate ratio, 0.87; 95% confidence interval [CI], 0.80 to 0.95), and the absolute risk reduction was 0.22% (95% CI, 0.10 to 0.34). The cumulative incidence of prostate cancer was higher in the screening group than in the control group (rate ratio, 1.30; 95% CI, 1.26 to 1.33). At a median of 23 years of follow-up, one death from prostate cancer was prevented for every 456 men (95% CI, 306 to 943) who were invited for screening, and one death from prostate cancer was averted for every 12 men (95% CI, 8 to 26) in whom prostate cancer was diagnosed, as compared with one death from prostate cancer prevented for every 628 men (95% CI, 419 to 1481) and one death averted for every 18 men (95% CI, 12 to 45) at 16 years of follow-up. CONCLUSIONS: Long-term follow-up confirms a sustained reduction in deaths from prostate cancer with PSA testing, alongside an improved harm-benefit ratio. Future screening strategies should adopt risk-based approaches to minimize overdiagnosis while maintaining clinical benefits. (Funded by the Dutch Cancer Society and others; ERSPC ISRCTN registry number, ISRCTN49127736.).