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Background and objective: Infection after transrectal prostate biopsy (TPBx) is a well-known risk. A comprehensive investigation of risk factors may identify measures for safe TPBx as an alternative to a change in biopsy route. The aim of this study was to identify risk factors for infection after TPBx. Methods: We included all outpatient TPBx cases in Region Kronoberg, Sweden, from January 2010 to December 2019. The primary outcome was post-TPBx infection, defined as prescription of antibiotics indicated for urinary tract infection (UTI) or inpatient care for infection within 30 d. We analysed the following factors in relation to post-TPBx infection: age, diabetes mellitus, prostate cancer diagnosed at index biopsy, previous prostate biopsy, two or more biopsies in the past 24 mo, a positive urine culture, two or more negative urine cultures (UCs) in the past 24 mo, antibiotic treatment grouped as four types, and medication for benign prostatic hyperplasia (BPH). Logistic regression was used to calculate odds ratios (ORs). Key findings and limitations: Of 5788 TPBx procedures in 4040 patients, 405 (7.0%) led to an infection and 170 (2.9%) to inpatient care for infection. Risk factors for post-TPBx infection (ORs 1.5-2.5) were diabetes mellitus, antibiotic treatment for a UTI, fluoroquinolone treatment, and a positive urine culture. Weaker risk factors (ORs 1.3-1.5) were non-UTI antibiotic treatment, BPH medication, and negative UCs before TPBx. Conclusions and clinical implications: Our results confirm that diabetes mellitus and previous UTI are risk factors for infection after TPBx. Lower urinary tract symptoms and treatment with any kind of antibiotic were associated with infection, which has not been previously reported. Patient summary: In a large population-based study from Sweden, we investigated which clinical factors increase the risk of an infection after transrectal prostate biopsy. Our results confirm that diabetes and a previous urinary tract infection are risk factors. We also found two new factors associated with the risk of infection after biopsy: lower urinary tract symptoms and any antibiotic treatment.
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BACKGROUND AND OBJECTIVE: We investigated whether adding 4Kscore as a reflex test to prostate-specific antigen (PSA) could improve the screening algorithm for prostate cancer (PC). METHODS: In the GÖTEBORG-2 PC screening trial, 38 000men (50-60 yr) were invited to PSA testing and, if elevated, followed by magnetic resonance imaging (MRI). For 571 men with PSA ≥3.0 ng/ml and evaluable outcomes, 4Kscore was calculated. The performance using a prespecified 4Kscore cutoff of 7.5% was evaluated. KEY FINDINGS AND LIMITATIONS: The area under the curve for 4Kscore to identify intermediate- and high-risk PC was 0.84 (95% confidence interval 0.79-0.89), and the positive predictive value, and negative predictive value were 15% (0.12-0.20) and 99% (97-100%), respectively. Of the 54 men diagnosed with intermediate- or high-grade PC, two had a 4Kscore cutoff below 7.5%, both with organ-confined intermediate-risk PC. Per 1000 men with elevated PSA, adding 4Kscore would have resulted in avoidance of MRI for 408 (41%) men, biopsies for 95 (28% reduction) men, and diagnosis of 23 low-grade cancers (23% reduction) while delaying the diagnosis of four men with intermediate-grade cancers (4%). CONCLUSIONS AND CLINICAL IMPLICATIONS: Including 4Kscore as a reflex test for men with elevated PSA reduces the need for MRI and biopsy markedly, and results in less overdiagnosis of low-grade PC at the cost of delaying the diagnosis of intermediate-grade PC in a few men. These results add further evidence for including new blood-based biomarkers in addition to PSA to improve the harm and benefit ratio of PC screening and reduce the need for resource-demanding MRI and biopsies. PATIENT SUMMARY: In this study, 4Kscore, a blood-based biomarker, as a reflex test for men with elevated prostate-specific antigen (PSA), reduces the need for magnetic resonance imaging and biopsy. These results support the inclusion of new blood-based biomarkers in addition to PSA.