Safety of Single-Dose Oral Cefaclor Prophylaxis in Transperineal Prostate Biopsy.

Abstract

Purpose: Transperineal prostate biopsy is essential for diagnosing prostate cancer; however, infection remains a clinically significant issue. We evaluated the safety and outcome of a single, prophylactic oral dose of cefaclor 500mg during transperineal prostate biopsy.

Patients and methods: This retrospective observational study included 127 patients who underwent transperineal prostate biopsy for suspected prostate cancer at our institution between April 2024 and October 2025. Biopsies were performed transperineally under spinal anesthesia. Cefaclor 500 mg was administered orally 30 minutes pre-operatively as a prophylactic antibiotic. We collected information on laboratory data, medication history, comorbidities, frailty, and infection risk for analysis.

Results: Among 127 patients, 73 (57.8%) were classified as prefrail or frail and 27 (21.2%) were identified as at risk of infection. The median initial prostate-specific antigen level was 9.92 ng/mL (interquartile range, 6.55-17.3 ng/mL). Fifty patients (39.3%) with polypharmacy and seventy-one (55.9%) with multimorbidity were noted. All patients were discharged after a 2-day hospital stay. Complications were observed in 36 patients (28.3%). Grade 1 and grade 2 Clavien-Dindo complications occurred in 33 patients (25.9%) and 3 patients (2.3%; urinary retention in 2 patients, fever in 1), respectively. One patient (0.7%) developed a urinary tract infection and underwent additional oral antibiotic therapy. No cases of rehospitalization or sepsis occurred. Among patients who underwent biopsy, 90 (70.8%) tested positive for cancer.

Conclusion: Single-dose oral cefaclor prophylaxis in TPB appears to be safe, with no serious post-procedural infections observed. Its effectiveness in frail or high-risk patients requires confirmation in future large prospective studies.