EvidenceAlerts

Roobol MJ, de Vos II, Mansson M, et al. European Study of Prostate Cancer Screening - 23-Year Follow-up. N Engl J Med. 2025 Oct 30;393(17):1669-1680. doi: 10.1056/NEJMoa2503223. (Original study)
Abstract

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.).

Ratings
Discipline Area Score
Family Medicine (FM)/General Practice (GP) 6 / 7
General Internal Medicine-Primary Care(US) 6 / 7
Public Health 6 / 7
Oncology - Genitourinary 6 / 7
Comments from MORE raters

General Internal Medicine-Primary Care(US) rater

A very relevant and important study that reviews how we should approach prostate cancer screening in primary care/public health.

Oncology - Genitourinary rater

This important update of the European experience screening with PSA is of interest for two important reasons: 1. it presents NNT in relationship to the PSA screening in general; and 2. it serves as a benchmark for newer and more targeted PSA screening strategies (such as using Fusion biopsies to sample persons with high PiRADS scores) that aim precisely at decreasing the number needed to harm. Newer biomarker-driven strategies will have to show superiority to this baseline in terms of efficacy too.

Public Health rater

Long follow-up with many participants (162 K!). There was a benefit to persistent follow up, but we also have newer tools to detect abnormalities. Life-expectancy is going up and that is an important variable as well.
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