No excess mortality after prostate biopsy: results from the European Randomized Study of Screening for Prostate Cancer.
OBJECTIVE
• To assess possible excess mortality associated with prostate biopsy among screening participants of the European Randomized Study of Screening for Prostate Cancer (ERSPC).


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.


CONCLUSIONS
• Prostate biopsy is not associated with excess mortality and fatal complications appear to be very rare.
Carlsson
Sigrid V
SV
Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sweden. sigrid.carlsson@gmail.com
Holmberg
Erik
E
Moss
Sue M
SM
Roobol
Monique J
MJ
Schröder
Fritz H
FH
Tammela
Teuvo L J
TL
Aus
Gunnar
G
Auvinen
Anssi P
AP
Hugosson
Jonas
J
D000368:Aged; D001707:Biopsy, Needle / Q000401:mortality*; D055088:Early Detection of Cancer / Q000401:mortality*; D004812:Epidemiologic Methods; D005387:Finland / Q000453:epidemiology; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D017430:Prostate-Specific Antigen / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology*; D018805:Sepsis / Q000209:etiology / Q000401:mortality*; D013548:Sweden / Q000453:epidemiology
D017430:Prostate-Specific Antigen