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Study Type – Harm (RCT)Level of Evidence 1bWhat’s known on the subject? and What does the study add?Prostate biopsy can potentially have fatal outcome. This is, however, rare. In the literature a few fatal cases of septicaemia have been reported as well as life-threatening rectal bleeding.Prostate biopsy is not associated with excess mortality and fatal complications seem to be very rare in a screening setting.•To assess possible excess mortality associated with prostate biopsy among screening participants of the European Randomized Study of Screening for Prostate Cancer (ERSPC).•From three centres in the ERSPC (Finland, The Netherlands and Sweden) 50 194 screened men aged 50.2–78.4 years were prospectively followed. A cohort of 12 959 first-time screening-positive men (i.e. with biopsy indication) was compared with another cohort of 37 235 first-time screening-negative men.•Overall mortality rates (i.e. other cause than prostate cancer mortality) were calculated and the 120-day and 1-year cumulative mortality were calculated by the Kaplan–Meier method, with a log-rank test for statistical significance.•Incidence rate ratios (RR) and statistical significance were evaluated using Poisson regression analyses, adjusting for age, total PSA level, screening centre and whether a biopsy indication was present, or whether a biopsy was actually performed or not.•There was no statistically significant difference in cumulative 120-day other cause mortality between the two groups of men: 0.24% (95% CI, 0.17–0.34) for screening-positive men vs 0.24% (95% CI, 0.20–0.30) for screening-negative men (P= 0.96). This implied no excess mortality for screening-positive men.•Screening-positive men who were not biopsied (n= 1238) had a more than fourfold risk of other cause mortality during the first 120 days compared to screening-negative men: RR, 4.52 (95% CI, 2.63–7.74) (P < 0.001), adjusted for age, whereas men who were actually biopsied (n= 11 721) had half the risk: RR, 0.41 (95% CI, 0.23–0.73) (P= 0.002), adjusted for age.•Only 14/31 (45%) of the screening-positive men who died within 120 days were biopsied and none died as an obvious complication to the biopsy.•Prostate biopsy is not associated with excess mortality and fatal complications appear to be very rare.