In an updated analysis published in The New England Journal of Medicine, Roobol et al reported long-term findings from the European Randomized Study of Screening for Prostate Cancer (ERSPC) on the survival benefit of prostate-specific antigen (PSA) screening. The study, which was initiated in 1993, represents one of the most comprehensive evaluations of population-based prostate cancer screening and its effects on mortality and overdiagnosis.
Study Details
The ERSPC was a multicenter, randomized trial conducted across eight European countries (the Netherlands, Belgium, Sweden, Finland, Italy, Spain, Switzerland, and France). A total of 162,236 men aged 55 to 69 years were randomly assigned between 1993 and 2003 to receive either repeated PSA screening (n = 72,888) or no screening (n = 89,348). The median age at random assignment was 60 years (interquartile range = 57–64 years). Participants were followed for up to 23 years, with data collection ending on December 31, 2020. The primary endpoint was prostate cancer mortality.
Participants in the screening group were offered between two and eight PSA tests, typically at 4-year intervals, while those in the control group received no organized screening invitation. Of the screened patients, 28% had at least one positive result, leading to transrectal ultrasound–guided prostate biopsy compliance rates of 89%. However, only 24% of the biopsies confirmed prostate cancer, illustrating ongoing concerns about overdiagnosis and potential overtreatment.
Key Results
After a median follow-up of 23 years, PSA screening resulted in a 13% reduction in prostate cancer mortality compared with no screening (rate ratio [RR] = 0.87; 95% confidence interval [CI] = 0.80–0.95). The absolute risk reduction was 0.22% (95% CI = 0.10–0.34), corresponding to one prostate cancer death prevented for every 456 men who were invited for screening and one death prevented per 12 men diagnosed with the disease. By contrast, at 16 years of follow-up, one death from prostate cancer was prevented for every 628 men invited for screening, and one death was averted for every 18 men diagnosed, indicating an improved harm-to-benefit profile over time. The cumulative incidence of prostate cancer was higher in the screening group (14%) than in the control group (12%), yielding a rate ratio of 1.30 (95% CI = 1.26–1.33).
According to the authors, this final analysis provides pivotal evidence supporting the long-term benefit of PSA testing, underscoring the importance of individualized, risk-adapted screening to optimize outcomes and minimize harm for men at risk of prostate cancer. “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,” they concluded.
Monique J. Roobol, PhD, of the Department of Urology at Erasmus Medical Center, Rotterdam, the Netherlands, is the corresponding author for the New England Journal of Medicine article.
Disclosure: This study was funded by the Dutch Cancer Society and others. For full disclosures of all study authors, visit nejm.org.
