PSA-based screening reduced the rate of death from prostate cancer by 20% but was associated with a high risk of overdiagnosis. (Current Controlled Trials number, ISRCTN49127736.)

Background The European Randomized study of Screening for Prostate Cancer (ERSPC) is a randomized multi-center trial with a predefined centralized database, analysis plan and core age group (55–69 years) evaluating prostate-specific antigen (PSA) testing in eight European countries. Methods The present results are based on prostate cancer (PCa) incidence and mortality truncated at 9, 11, and 13 years of follow-up in the intervention arm (offered PSA testing) relative to the control arm. A secondary analysis corrected for selection bias due to non-participation was performed. Because of incomplete follow-up, only incidence and no mortality data at 9 years follow-up are reported for the French centers. Findings The rate ratio (RR) of PCa incidence between the intervention and control arms was 1.91 after 9 years (1.64 including France), 1.66 after 11 years and 1.57 after 13 years. The RR of PCa mortality was 0.85, 0.78 and 0.79 at 9, 11 and 13 years respectively (95% confidence interval 13-year 0.69–0.91, p = 0.001). This corresponds to a relative risk reduction of 21% and an absolute risk reduction of death from PCa at 13 years of 0.11 per 1,000 person-years or 1.28 per 1,000 men randomized, which is equivalent to one PCa death averted per 781 men invited for screening or one per 27 additional PCa detected. PCa mortality reduction in screened men after adjustment for non–participation was 27%. Interpretation This update of ERSPC confirms a substantial PCa mortality reduction due to PSA testing, with a substantially increased absolute effect at 13 years compared to findings after 9 and 11 years. Funding All sources of funding per center are indicated in the “Web extra material” section. Trial identification This trial is registered under Current Controlled Trials number: ISRCTN49127736.

Summary Background Several trials have evaluated the effect of prostate-specific antigen (PSA)-based screening on prostate cancer (PC) mortality, with conflicting results. We report on the mortality in the European Randomized Trial of Screening for Prostate Cancer (ERSPC) with two added years of follow-up. Methods The ERSPC is a randomized screening trial in men aged 50 – 74 years (N=182,160) at entry, with a predefined core age group of 55 – 69 years (N=162,388) conducted in eight European countries Men randomized to the intervention arm were offered prostate specific antigen (PSA)-based screening while those in the control arm were not offered screening. The primary outcome is PC mortality. Results After a median follow-up of 11 years the relative risk reduction for PC death in the intention to screen analysis was 21% (risk ratio 0.79, 95%CI 0.68 – 0.91, p=0.001), and 29% for screened men after correction for non-compliance in the core age group. The absolute difference in mortality amounted to 0.10 per 1000 person years or 1.07 per 1000 men randomized. The rate ratio of PC mortality during the follow-up years 10 -11 was 0.62 (95% CI 0.45 – 0.85, P=0.003). The numbers needed invite (NNI) and detect (NND) to prevent one PC death amounted to 1055 and 37 at 11 years of follow-up and 936 and 33 for the entire follow-up. There was no difference in all-cause mortality. Conclusions Two added years of follow-up consolidate our previous finding that PSA-based screening reduces PC mortality but does not affect all cause mortality. (The trial is registered in the ISRCTN registry under number 49127736.)