Omission of postoperative antibiotic prophylaxis after radical cystectomy: Interim results of the A-PURC phase III randomized non-inferiority trial.

Abstract

e23314 Background: Urinary tract infection (UTI) is a common cause of readmission following radical cystectomy(RC). The optimal role of postoperative antibiotic prophylaxis remains uncertain. The A-PURCPhase III randomized non-inferiority trial evaluates whether omitting postoperative antibioticprophylaxis is non-inferior to standard prophylaxis in preventing UTIs after RC. Methods: Patients with muscle-invasive bladder cancer (MIBC) undergoing RC at the university ofMinnesota were randomized 1:1 to either a prophylaxis or control arm, stratified by urinarydiversion type—ileal conduit (IC) or neobladder (NB). The prophylaxis arm received dailynitrofurantoin until ureteral stent removal (10 days for IC; 21 days for NB). The primaryendpoint was 30-day UTI incidence. Secondary endpoints included 90-day UTI incidence andUTI-related readmission rates at 30 and 90 days. Logistic regression analysis and Kaplan-Meiercurves were used to compare UTI-free survival between the two groups.This is a prespecified interim analysis per protocol (data cutoff: December 31, 2025). Results: At interim analysis, 33 patients were enrolled: 17 prophylaxis (9 IC, 8 NB) and 16 control (12 IC,4 NB). The 30-day UTI rate was 12% in both arms. There was also no difference in 90-day UTIincidence (26% vs 24%; P = 0.99), 30-day UTI-related readmission rate (12% vs 6%; P = 0.6), or 90-day UTI-related readmission rate (26% vs 18%; P = 0.8) between the prophylaxis and controlarms. (Table 1) There was also no significant difference in UTI-free survival between arms. Conclusions: Interim findings from the A-PURC trial suggest that omission of postoperative antibioticprophylaxis after RC does not increase UTI or UTI-related readmission rates within 90 days.These results support a more selective, stewardship-driven approach to postoperativeantibiotic use after RC. The trial remains ongoing to confirm non-inferiority in an expandedcohort. Clinical trial information: NCT06190197 . Comparison of postoperative complications and UTI-related readmission betweengroups. Variable Control arm (n = 16) Prophylaxis arm (n = 17) P value Neoadjuvant chemotherapy, No. (%) 8 (50%) 9 (53%) 1 CCI (age-adjusted), median (IQR) 3 (2.5) 3 (1.5) 1 Length of stay (IQR), days 6.5 (4) 6 (3.5) 0.335 Overall complication rate (0–30 d), n (%) 9 (56%) 13 (76%) 0.282 UTI rate (0–30 d), n (%) 2 (12%) 2 (12%) 1 UTI related readmission rate (0–30 d), n (%) 2 (12%) 1 (6%) 0.601 Overall complication rate (31–90 d), n (%) 4 (25%) 10 (58%) 0.17 UTI rate (31–90 d), n (%) 2 (12%) 2 (12%) 0.99 UTI related readmission rate (31–90 d), n (%) 2 (12%) 2 (12%) 0.99 BMI, body mass index; IQR, interquartile range; UTI, urinary tract infection.