Introduction: Prostate biopsy for cancer detection may be performed either through transrectal (TR-Bx) or transperineal (TP-Bx) approach. Recently, TP-Bx approach is being promoted as the superior alternative to TR-Bx due to potentially lower complication rates. However, there are conflicting clinical guidelines regarding the preferred option, and high level comparative evidence is lacking. We conducted a randomized clinical trial, sufficiently powered to determine if TP-Bx is associated with lower risk of infectious and other complications (ClinicalTrials.gov: NCT04081636). Methods: 763 men undergoing prostate biopsy were recruited for the randomized study comparing TR-Bx and TP-Bx procedures. All procedures were performed in the office, under local anesthesia. The primary outcome was the 30-day incidence of post-biopsy composite infectious complications (including fever, antibiotic prescriptions, genitourinary infection, sepsis, office or emergency room visits, or hospitalization). Secondary outcome was the 30-day post-biopsy composite non-infectious complication rate (including urinary retention, any hemorrhage requiring intervention, or unplanned heath care utilization). Follow up and data collection included clinic visit at 2 weeks, phone survey at 30 day, and medical record review after 30 days. Results: 718 men completed either the TR-Bx (351) or the TP-Bx (367) procedure and the required follow up. The mean (±SD) age was 64.7 (6.9) years. A composite infectious complication event occurred in 9 patients (2.6%) in the TR-Bx group, and 10 patients (2.7%) in the TP-Bx group (risk ratio 1.06; 95% CI, 0.43 to 2.65; p= 0.99). Fever was the most frequent event, reported by 6 patients (1.7%) in each group. Overnight hospitalization required for 2 patients (0.55%) in TR-Bx and 1 patient (0.27%) in TP-Bx group. There were no episodes of sepsis in either group. There were no between-group differences in the occurrence of any of the component outcomes. A composite non-infectious event occurred in 6 (1.7%) and 8 (2.2%) patients in the TR-Bx and TP-Bx groups, respectively (OR 1.28; 95% CI, 0.44 to 3.73; p= 0.79). Phone call to the office was the most frequent event that was noted in 3 patients (0.9%) in the TR-Bx and 7 patients (1.9%) in TP-Bx group. Urinary retention occurred in 1 patient in each group, and no patients required hospitalization. Conclusions: Among men undergoing biopsy for prostate cancer detection, transrectal and transperineal prostate biopsy procedures are associated with a similar risk of infectious and non-infectious complications. SOURCE OF Funding: Capital Region Medical Research Institute, SUNY-School of Public Health
