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Randomized Controlled Trial
. 2011 Jun;107(12):1912-7.
doi: 10.1111/j.1464-410X.2010.09712.x. Epub 2010 Oct 15.

No excess mortality after prostate biopsy: results from the European Randomized Study of Screening for Prostate Cancer

Sigrid V Carlsson  1 , Erik Holmberg, Sue M Moss, Monique J Roobol, Fritz H Schröder, Teuvo L J Tammela, Gunnar Aus, Anssi P Auvinen, Jonas Hugosson
Affiliations
Randomized Controlled Trial

No excess mortality after prostate biopsy: results from the European Randomized Study of Screening for Prostate Cancer

Sigrid V Carlsson et al. BJU Int. 2011 Jun.

Abstract

Objective: • To assess possible excess mortality associated with prostate biopsy among screening participants of the European Randomized Study of Screening for Prostate Cancer (ERSPC).

Patients and methods: • 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.

Results: • 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.

Conclusion: • Prostate biopsy is not associated with excess mortality and fatal complications appear to be very rare.

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