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. Aim was to investigate infectious complications of TRBP under FOS as a single dose. Methods All TRBPs under FOS 3000 mg as a single dose between 1st of July 2020 and 30th of June 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 to 22 cores were taken (median 14). PSA was 0.1 to 1224ng/ml (median 7.7ng/ml), prostate volume 5 to 263ml (median 50ml). 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%, FOS single dose therefore represents sufficient antibiotic prophylaxis for TRBP in this collective. FOS as a single dose should be re-evaluated in a prospective study to obtain approval in Germany for this indication.
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