KEY TAKEAWAYS
- The ProBE-PC study aimed to determine the occurrence of post-biopsy infectious complications in pts who underwent prostate biopsies.
- The primary endpoint was to identify post-biopsy infectious complications within 30 days.
- Researchers found no noteworthy variance in the rate of complications, such as infections, between TP-Bx and TR-Bx techniques for prostate biopsy in cancer detection.
This randomized clinical trial evaluated the effectiveness of TR-Bx and TP-Bx procedures on 763 men who underwent prostate biopsies in-office with local anesthesia. The study aimed to determine the occurrence of post-biopsy infectious complications (including fever, antibiotic prescriptions, genitourinary infection, sepsis, office or emergency room visits, or hospitalization) within 30 days as the primary outcome and non-infectious complications (including urinary retention, any hemorrhage requiring intervention, or unplanned health care utilization) as the secondary outcome. Follow-up involved a two-week clinic visit, a phone survey at 30 days, and a review of medical records after 30 days.
In the study, 718 men underwent either the transrectal (TR-Bx) (351) or the transperineal (TP-Bx) (367) procedure and were followed up accordingly. The mean age was found to be 64.7 (±6.9) years. Nine patients (2.6%) in the TR-Bx group and 10 (2.7%) in the TP-Bx group experienced a composite infectious complication. The risk ratio was 1.06; 95% CI, 0.43 to 2.65; p=0.99. The most commonly reported event was fever, with six patients (1.7%) experiencing it in each group. Only three patients required overnight hospitalization,2 in TR-Bx (0.55%) and 1 in TP-Bx (0.27%) group. Neither group experienced sepsis. There were no significant differences in the two groups’ component outcomes. A composite non-infectious event was experienced by 6 (1.7%) and 8 (2.2%) pts in the TR-Bx and TP-Bx groups, respectively (OR 1.28; 95% CI, 0.44 to 3.73; p=0.79). Phone calls to the office were the most common event in the TR-Bx group with three patients (0.9%) and in the TP-Bx group with seven patients (1.9%). One patient inPSA Infectio each group experienced urinary retention; no hospitalizations were needed.
Both transrectal and transperineal prostate biopsy procedures have similar risks of infectious and non-infectious complications in men undergoing biopsy for prostate cancer detection.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003426.03
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04081636
Mian, Badar M.; Feustel, Paul J.; Aziz, Asef; Kaufman, Ronald; Avulova, Svetlana; Bernstein, Adrien; Fisher, Hugh LBA03-03 INFECTIOUS AND NON-INFECTIOUS COMPLICATIONS FOLLOWING PROSTATE BIOPSY: A RANDOMIZED CLINICAL TRIAL, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4 doi: 10.1097/JU.0000000000003426.03
