Efficacy and Safety of Two Fosfomycin Regimens as Antimicrobial Prophylaxis for Transrectal Prostate Biopsy: A Randomised Study

Abstract

<b><i>Purpose:</i></b> Prostate biopsy is the gold standard for prostate cancer diagnosis; unfortunately, this procedure is not free from complications. Recent studies have shown an increase in antibiotic resistance. The aim of our prospective randomized study was to evaluate the efficacy and safety of a prostate biopsy prophylaxis protocol using 2 vs. 3 fosfomycin doses. <b><i>Methods:</i></b> Two hundred and ninety-seven patients undergoing transrectal systematic ultrasound (US)-guided (<i>n</i> = 277) or transrectal fusion prostate biopsy (<i>n</i> = 20) were prospectively evaluated and randomized by date of birth, to receive 2 (even years, group A) versus 3 doses of fosfomycin (odd years, group B), and prospectively evaluated. <b><i>Results:</i></b>Two hundred and ninety-seven patients were randomized to group A (<i>n</i> = 162) or group B (<i>n</i> = 135). The 2 groups were comparable with respect to age, comorbidity, PSA value, prostate volume, operative time and urine culture results. Out of 297 patients, 44 (14.8%) developed complications after the procedure; 2.7% (8/297) of patients developed fever >38° requiring hospitalization (6 [3.7%] in group A and 2 [1.5%] in group B, <i>p</i> = 0.29). Patients who underwent fusion biopsy were more frequently readmitted in comparison with patients undergoing US-guided prostate biopsy (<i>p</i> = 0.000). <b><i>Conclusion:</i></b> The low fever and prostatitis rate suggest that fosfomycin prophylaxis is safe and efficient. There is no significant difference in clinical outcome between the 2 dosage regimens.

Comparison of Complication Rates with Antibiotic Prophylaxis with Cefpodoxime Versus Fluoroquinolones After Transrectal Prostate Biopsy

“…To the best of our knowledge, there is no published study addressing only cefpodoxime as antibiotic prophylaxis for transrectal prostate biopsy. However, several investigators have compared different antibiotic regimes as antibiotic prophylaxis for transrectal prostate biopsy since the EMA published their recommendation restricting administration of fluoroquinolones because of severe side effects [23][24][25]. For example, Cai et al [26] investigated whether fosfomycin has sufficient efficacy as antibiotic prophylaxis for transrectal prostate biopsy and reported a symptomatic urinary tract infection rate of 1.6%.…”

Antibiotikaprophylaxe bei transrektaler Prostatabiopsie

“…Die Möglichkeit alternativer oraler PAP-Substanzen wurde intern diskutiert. So wurde neben Fosfomycin [ 7 , 10 , 18 ] auch eine Kombination aus Pivmecillinam und Amoxicillin/Clavulansäure [ 1 ] erörtert. Fosfomycin-PAP ist insbesondere für Erreger mit niedriger minimaler Hemmkonzentration empfohlen [ 21 ] und Fosfomycin ist ein wertvolles Breitspektrumreserveantibiotikum, dessen Resistenzentwicklung mit geringen therapeutischen Spiegeln und vermehrtem Einsatz assoziiert ist, sodass ein Selektionsdruck bei vermehrt Nicht-Harnwegsinfektions(HWI)-Indikationen zu befürchten ist [ 13 , 23 ].…”