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Introduction: According to guidelines, transrectal random biopsy of the prostate (TRBP) is performed under antibiotic prophylaxis (AP). Fosfomycin-trometamol (FOS) is not approved in Germany, but TRBP as indication was listed in the product information falsely. The aim was to investigate infectious complications of TRBP under FOS as a single dose.
Methods: All TRBPs under FOS 3,000 mg as a single dose between July 1, 2020, and June 30, 2021, at a university institution were recorded. 357 patients (41-85 years old, median 66) were included. 243 received first TRBP, 321 TRBP were MRI-fusionated. 10-22 cores were taken (median 14). Prostate-specific antigen (PSA) was 0.1-1224 ng/mL (median 7.7 ng/mL), prostate volume 5-263 mL (median 50 mL). Analysis was performed using Chi square test or Fisher's exact test, Mann-Whitney U test, and t test.
Results: Four patients suffered an infection (1.1%), without significant difference according to age (p = 0.849), PSA (p = 0.957), number of cores (p = 0.905), and increase in volume (p = 0.456). Limiting is the retrospective character.
Conclusion: The complication rate was 1.1%, and FOS single dose therefore represents sufficient AP for TRBP in this collective. FOS as a single dose should be reevaluated in a prospective study to obtain approval in Germany for this indication.
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