Background
Randomized controlled trial (European Randomized Study of Screening for Prostate Cancer). N=162,236 men, core age 55–69 years, across eight European countries, randomized to PSA screening vs no-screening control. This report extends follow-up to a median of 23 years to assess durability of the prostate cancer mortality benefit and harm-benefit balance.
Interventions and follow up
Arm A: PSA screening (repeated testing offered)
Arm B: Control (no screening invitation)
Primary endpoint: Prostate cancer mortality
Median follow up: 23 years
Arm B: Control (no screening invitation)
Primary endpoint: Prostate cancer mortality
Median follow up: 23 years
Results
Prostate cancer mortality: 13% reduction with screening vs control (RR 0.87, 95% CI 0.80–0.95); absolute risk reduction 0.22% (95% CI 0.10–0.34)
Number needed to invite (NNI): 456 men invited to prevent one death (vs 628 at 16-year follow-up)
Incidence: Higher cumulative diagnosis with screening (RR 1.30, 95% CI 1.26–1.33), reflecting earlier detection and overdiagnosis
Number needed to invite (NNI): 456 men invited to prevent one death (vs 628 at 16-year follow-up)
Incidence: Higher cumulative diagnosis with screening (RR 1.30, 95% CI 1.26–1.33), reflecting earlier detection and overdiagnosis
Adverse events
Overdiagnosis: Roughly 30% more cancers detected in the screening arm, many indolent, driving overtreatment risk
Screening-related harms: Anxiety from false positives and infrequent biopsy-related complications
Screening-related harms: Anxiety from false positives and infrequent biopsy-related complications
Conclusions
After 23 years, PSA screening sustains a 13% prostate cancer mortality reduction with an improving harm-benefit ratio (NNI falling to 456). Screening prevents prostate cancer deaths, but substantial overdiagnosis necessitates risk-stratified screening and de-escalated management of low-grade disease.
Key Limitations
Substantial overdiagnosis persists, with additional diagnoses per death prevented. Contamination: control participants may have self-screened, biasing toward the null. Generalizability is limited to mostly European populations, and PSA-testing patterns have changed since trial inception.
Clinical Context
The ERSPC long-term update supports PSA screening when paired with risk stratification (family history, baseline PSA) and shared decision-making in the 55–69 age group. It reinforces de-escalated management (active surveillance) of low-grade disease to mitigate overtreatment. ESMO and EAU endorse risk-adapted, shared-decision screening rather than universal PSA testing.