European Study of Prostate Cancer Screening — 23-Year Follow-up
- Study type
- Clinical trial
- Study name
- ERSPC
- Design
- Randomised multicentre population-based screening trial in eight European countries
- Sample size
- 162,236 men in the core age group of 55 to 69 years
- Source
- N Engl J Med · 2025
- Trial registration
- ISRCTN49127736
In plain words
In this large European study, more than 160 thousand men aged 55 to 69 were divided into two groups: one invited for regular PSA testing and one not invited. After 23 years, deaths from prostate cancer were about 13% lower in the screening group. But screening also found cancers that might never have caused a problem. That is why the decision about a PSA test should be made after talking it through with a doctor.
Key results
Treatment arms and regimens
No drugs (screening trial). Invitation to repeated PSA testing; PSA equal to or greater than 3.0 ng/mL was considered a positive test and was followed by systematic transrectal ultrasound-guided prostate biopsy. Screening was mostly every 4 years (range 2 to 7 years) up to age 70 (range 50 to 75 years), and the interval and procedural details varied between centres.
No invitation to screening (usual care, no active screening).
Source of the regimen details: No drugs (screening trial); screening protocol (PSA threshold and screening interval) from the full text of the ERSPC report with 16 years of follow-up (Eur Urol 2023; PMC10759255); intervention-related deaths from PMC8655382
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Men aged 55 to 69 years (predefined core age group) in eight European countries, randomly assigned from 1993 onwards to a screening or control group.
Endpoints
Primary endpoint: death from prostate cancer. Other endpoints: cumulative incidence of prostate cancer, number of men who need to be invited or diagnosed to prevent one death.
Safety and side effects
The main harms of screening are overdiagnosis (a 30% increase in cumulative cancer incidence) and its consequences, namely additional biopsies and treatment of cancers that might never have caused harm.
In a separate ERSPC analysis with 16 years of follow-up (Eur Urol Open Sci 2021), 34 intervention-related deaths (complications of the screening process, treatment or follow-up) were identified: 21 deaths in the screening group and 13 in the control group; overall risk 1.41 per 10,000 randomised men (95% CI 0.99 to 1.99), ranging from 0 to 7.0 per 10,000 across centres.
Clinical significance and place in guidelines
ERSPC is the most important randomised evidence for the effect of PSA screening on prostate cancer mortality. Its results underpin the USPSTF recommendation of shared decision-making and the risk-based screening approach (using MRI and risk calculators) in the EAU guideline. The 23-year follow-up showed that the benefit-to-harm ratio improves over time.
Limitations
The screening protocol (interval and PSA threshold) was not the same across countries; some men in the control group probably had PSA testing outside the study (contamination), which may underestimate the benefit; the diagnostic pathway during the study did not include MRI and may differ from current practice.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.