Fosfomycin versus ciprofloxacin for transrectal prostate biopsy: An open randomised controlled multicentre drug trial

Objective: Antibiotic prophylaxis reduces infection risk following transrectal prostate biopsy. Studies in countries with high antibiotic resistance show that fosfomycin, given an hour or more before biopsy, has equal or better outcomes than ciprofloxacin. This study aimed to evaluate if fosfomycin, administered immediately before biopsy, is as effective as ciprofloxacin in Sweden, where antibiotic resistance is low. Material and Methods: A randomised, non-inferiority study of different antibiotic prophylactic regimes, including men undergoing transrectal prostate biopsy, was conducted. A total of 3448 patients were planned to be included. Primary outcome was hospitalisation due to urinary tract infection (UTI) within 14 days. Men without risk factors for infection received either fosfomycin or ciprofloxacin immediately before biopsy. Patients with risk factors received additional doses post-biopsy. Results: The study was stopped by the safety board after enrolment of 42 men. Four of 20 men (25%) in the fosfomycin group were hospitalised due to UTI, including two with positive blood cultures for Pseudomonas , whereas no hospitalisations (0%) occurred in the ciprofloxacin group. The main limitation was the small sample size. Conclusion: Fosfomycin administered immediately before biopsy was not supported by this study. The results may be skewed by the high incidence of Pseudomonas infections. Level of evidence: 2