Investigating infectious complications from transrectal vs. transperineal prostate biopsies in the era of MRI-targeted biopsies
Prostate cancer remains one of the most commonly diagnosed malignancies in men worldwide, and accurate diagnosis and staging are critical to improving outcomes. Prostate biopsy has become a key component of the diagnosis of prostate cancer and guides treatment. Historically, the transrectal route has been used, but more recently, the transperineal approach has been described, and the evidence base for its superiority over the transrectal approach is growing, most notably with concerns over infection rates with the transrectal approach. With these concerns in mind, Hu et al. performed a randomised trial looking at outcomes of transperineal vs. transrectal prostate biopsies with a specific focus on infective complications whilst maintaining diagnostic accuracy (1).
This large, multi-centre, United States (US)-based trial by Hu et al. contributes towards the refining of prostate biopsy techniques, especially considering the known complication of biopsy-associated infections, including sepsis, which has become increasingly recognised in the era of widespread antibiotic resistance. A total of 658 patients with suspected clinically significant prostate cancer [90% of patients had lesions rated Prostate Imaging Reporting and Data System (PI-RADS) 3–5] were randomised to either transperineal or transrectal magnetic resonance imaging (MRI)-targeted biopsy, with systematic biopsy included in both arms. The primary outcome was the rate of infectious complications, specifically sepsis, within 30 days of the procedure. Secondary outcomes included diagnostic accuracy and patient-rated procedural pain and anxiety.
One of the major concerns over the transrectal approach to prostate biopsies is the introduction of gastrointestinal (GI) flora into the prostate, leading to, in some cases, severe and life-threatening sepsis. Various methods of antibiotic prophylaxis have been trialled, with fluoroquinolones being a mainstay of treatment prior to concerns regarding high rates of resistance and the side effects related to this group of medications (2-4). The study protocol for the transrectal arm of the study included rectal culture swabs to screen for fluoroquinolone-resistant flora, and targeted anti-microbial prophylaxis was given. That level of targeted prophylaxis is not routinely performed worldwide. No routine antimicrobial prophylaxis was given to the transperineal arm.
Multiple studies have reported lower infection rates after transperineal vs. transrectal biopsies (5-8). The 2024 European Association of Urology (EAU) guidelines advocate for abandoning the transrectal approach, allowing for logistical challenges (9). This study reported a 0% infection rate post-transperineal prostate biopsy without giving prophylactic antibiotics which is highly commendable, though must be viewed alongside the very low infection rate in the transrectal biopsy group of 1.4% with no statistical significance noted between the groups [difference, −1.4%; 95% confidence interval (CI): −3.2%, 0.3%; P=0.059].
Key to the development of new sampling techniques is that the diagnostic yield is comparable to or better than the industry standard. A 2019 meta-analysis of eight studies showed evidence that transperineal MRI-targeted biopsies might show an increased detection rate of clinically significant prostate cancer (62% vs. 41%) (10). Hu et al. detected clinically significant prostate cancer in 53% of the transperineal group and 50% of the transrectal group, a non-statistically significant difference (adjusted difference, 2.0%; 95% CI: −6.0%, 10%). That meta-analysis of eight studies included 328 patients in the transperineal group and 315 in the transrectal group; therefore, this study adds useful data to the field (1,10).
This study affirms the growing body of evidence that, where transperineal biopsy is technically feasible and safe, it should be the first-line option for obtaining tissue to diagnose prostate malignancy for clinicians seeking to balance diagnostic efficacy with patient safety. It has demonstrated a lower infection risk without contributing to antimicrobial resistance whilst maintaining diagnostic accuracy.
Acknowledgments
None.
Footnote
Provenance and Peer Review: This article was commissioned by the editorial office, Translational Andrology and Urology. The article has undergone external peer review.
Peer Review File: Available at https://tau.amegroups.com/article/view/10.21037/tau-2025-493/prf
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References
- Hu JC, Assel M, Allaf ME, et al. Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial. Eur Urol 2024;86:61-8. [Crossref] [PubMed]
- Medicines and Healthcare Products Regulatory Agency. Fluoroquinolone antibiotics: must now only be prescribed when other commonly recommended antibiotics are inappropriate. 2024. Available online: https://www.gov.uk/drug-safety-update/fluoroquinolone-antibiotics-must-now-only-be-prescribed-when-other-commonly-recommended-antibiotics-are-inappropriate
- European Medicines Agency. Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics. Available online: https://www.ema.europa.eu/en/news/disabling-potentially-permanent-side-effects-lead-suspension-or-restrictions-quinolone-fluoroquinolone-antibiotics
- Food and Drug Administration. FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects. 2016. Available online: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-updates-warnings-oral-and-injectable-fluoroquinolone-antibiotics
- Lam PW, Wong AHG, Chun TTS, et al. Prostate cancer detection, tolerability and safety of transperineal prostate biopsy under local-anaesthesia versus standard transrectal biopsy in biopsy-naïve men: a pragmatic, parallel group, randomized-controlled study. In: Hong Kong Urological Association 26th Annual Scientific Meeting, 2021. Hong Kong: Hong Kong Urological Association; 2021.
- Pradere B, Veeratterapillay R, Dimitropoulos K, et al. Nonantibiotic Strategies for the Prevention of Infectious Complications following Prostate Biopsy: A Systematic Review and Meta-Analysis. J Urol 2021;205:653-63. [Crossref] [PubMed]
- Bennett HY, Roberts MJ, Doi SA, et al. The global burden of major infectious complications following prostate biopsy. Epidemiol Infect 2016;144:1784-91. [Crossref] [PubMed]
- Berry B, Parry MG, Sujenthiran A, et al. Comparison of complications after transrectal and transperineal prostate biopsy: a national population-based study. BJU Int 2020;126:97-103. [Crossref] [PubMed]
- European Association of Urology. EAU Guidelines on Prostate Cancer - Diagnostic Evaluation. 2024. Available online: https://uroweb.org/guidelines/prostate-cancer/chapter/diagnostic-evaluation
- Tu X, Liu Z, Chang T, et al. Transperineal Magnetic Resonance Imaging-Targeted Biopsy May Perform Better Than Transrectal Route in the Detection of Clinically Significant Prostate Cancer: Systematic Review and Meta-analysis. Clin Genitourin Cancer 2019;17:e860-70. [Crossref] [PubMed]

