(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL between April 28 and May 1st, 2023, was host to a late breaking cancer abstract session. Dr. Badar Mian presented the results of a randomized controlled trial comparing infectious and non-infectious complications among patients undergoing a transrectal versus transperineal biopsy.
Tissue diagnosis of prostate cancer is currently performed either through a transrectal (TR-Bx) or transperineal (TP-Bx) approach. Over the past few years, there has been an increased uptake of the transperineal approach, due to reported decreased rates of post-biopsy infectious complications. This has been reflected in the latest updates of the EAU guidelines strongly recommending the use of the TP-Bx approach.
However, there is a paucity of high-level, randomized clinical evidence to inform this decision. As such, the investigators conducted a randomized clinical trial, sufficiently powered to determine if TP-Bx is associated with lower risk of infectious and other complications, compared to the TR-Bx approach (ClinicalTrials.gov: NCT04081636).
This trial recruited 763 men undergoing a prostate biopsy, randomized to either a TR or TP-Bx. All procedures were performed in the office, under local anesthesia. The primary outcome was the 30-day incidence of post-biopsy composite infectious complications, defined as any of:
- Fever
- Antibiotic prescriptions
- Genitourinary infections
- Sepsis
- Office or emergency room visit
- Hospitalization
The secondary outcome was the 30-day post-biopsy composite non-infectious complication rate, which included any of:
- Urinary retention
- Any hemorrhage requiring intervention
- Unplanned health care utilization
Follow up and data collection included a required 2-week clinic visit, phone survey at day 30, and a medical record review after 30 days.
718 men were randomized to either the TR-Bx (n=351) or the TP-Bx (n=367) approach. All patients completed the procedure and had follow-up data available. Mean patient age was 64.7 years (SD: 6.9). There were no significant differences in the post-biopsy infectious complication risks between the two groups. Am 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. Significantly, there were no episodes of sepsis in either group. There were no between-group differences in the occurrence of any of the infectious 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.
Dr. Mian concluded that among men undergoing a prostate biopsy for prostate cancer detection, the transrectal and transperineal approaches are associated with a similar risk of infectious and non-infectious complications.
Presented by: Badar Mian, MD, Professor of Surgery, Division of Urology, Albany Medical College, Albany, NY
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023