Chemoprophylaxis during transrectal prostate needle biopsy: critical analysis through randomized clinical trial.

Purpose: To compare the efficacy of three chemoprophylaxis approaches in prevention of post-transrectal biopsy infectious complications (TBICs).

Methods: Patients were randomly assigned to receive ciprofloxacin 3 days 500 mg B.I.D 3 days starting the night prior to biopsy (standard prophylaxis), augmented prophylaxis using ciprofloxacin and single preprocedure shot of 160 mg gentamicin IM (augmented prophylaxis) and rectal swab culture-based prophylaxis (targeted prophylaxis). Patients were assessed 2 weeks prior to biopsy, at biopsy and 2 weeks after. Primary end point was occurrence of post-TBICs that included simple UTI, febrile UTI or sepsis. Secondary end points were post-biopsy change in the inflammatory markers (TLC, ESR and CRP), unplanned visits, hospitalization and occurrence of fluoroquinolones resistance (FQ-R; bacterial growth on MacConkey agar plate with 10 μg/ml ciprofloxacin) in the fecal carriage of screened men.

Results: Between April/2015 and January/2017, standard, augmented and targeted prophylaxes were given to 163, 166 and 167 patients, respectively. Post-TBICs were reported in 43 (26%), 13 (7.8%) and 34 (20.3%) patients following standard, augmented and targeted prophylaxes protocols, respectively (P = 0.000). Post-TBICs included UTI in 23 (4.6%), febrile UTI in 41 (8.2%) and sepsis in 26 (5.2%) patients. Significantly lower number of post-biopsy positive urine culture was depicted in the augmented group (P = 0.000). The number of biopsy cores was statistically different in the three groups (P = 0.004). On multivariate analysis, augmented prophylaxis had independently lower post-TBICs (OR 0.2, 95% CI 0.1-0.4, P = 0.000) when compared with the other two groups regardless of the number of biopsy cores taken (OR 1.07, 95% CI 0.95-1.17, P = 0.229). Post-biopsy hospitalization was needed in four (2%), one (0.6%) and ten (6%) patients following standard, augmented and targeted prophylaxes, respectively (P = 0.014). However, sepsis-related hospitalization was not statistically different. Post-biopsy changes in the inflammatory markers were significantly less in augmented prophylaxis (P < 0.05). FQ-R was depicted in 139 (83.2%) of the screened men.

Conclusion: Augmented prophylaxis with single-dose gentamicin is an effective and practical approach. Targeted prophylaxis might be reserved for cases with contraindication to gentamicin.