Complications of initial prostate biopsy in a European randomized screening trial.

Abstract

BACKGROUND: Transrectal prostate needle biopsy (PNB) is a standard procedure for the diagnosis of prostate cancer. We recently found an increasing frequency of hospitalization with infectious complications associated with PNB over time. OBJECTIVE: To perform an updated analysis of overall complication rates in a large screening population over the past 18 years and to examine possible predictors of complications on initial PNB. DESIGN, SETTING AND PARTICIPANTS: From 1993-2011, 7216 men underwent initial lateralized sextant PNB in European Randomized Study of Screening for Prostate Cancer (ERSPC) Rotterdam. After 2 weeks a questionnaire was administered to 6962 men regarding PNB-related complications. Outcome Measurements & Statistical Analysis: Overall complication rates as well as specific complications (hematuria for >3 days, hematospermia, significant pain after biopsy, fever, and hospitalizations) were prospectively recorded. Multivariable logistic regression models were performed to assess the relationship between age, comorbidities, and prostate volume with specific complications. RESULTS AND LIMITATIONS: A total of 4674 (67.1%) men reported any sequelae after initial PNB, with hematospermia as the most frequent (53.8%), followed by hematuria (24.3%). Significant pain (4.8%), fever (4.1%), and hospital admission (0.7%) were reported less frequently. Hematospermia was significantly more likely in younger men with fewer comorbidities and smaller prostate volume; whereas hematuria was significantly more frequent among men with increasing comorbidities and prostate volume. In addition, pain was inversely associated with age and was also reported less frequently during later years of biopsy. Limitations of our study include the use of sextant biopsies and a relatively healthy population, while strengths include the large sample size and data on patient-specific covariates. CONCLUSION: Many men experience minor complications after initial PNB, although the frequency of specific complications such as hematospermia and hematuria differed based upon factors such as prostate volume and comorbidities. Overall, these data are useful to counsel patients who are undergoing their first PNB on the frequency of complications in a screening population.