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Transperineal versus transrectal magnetic resonance imaging–targeted and systematic prostate biopsy to prevent infectious complications: The PREVENT randomized trial

  • Jim C. Hu,
  • Melissa Assel,
  • Mohamad E. Allaf,
  • Behfar Ehdaie,
  • Andrew J. Vickers,
  • Andrew J. Cohen,
  • Benjamin T. Ristau,
  • David A. Green,
  • Misop Han,
  • Michael E. Rezaee,
  • Christian P. Pavlovich,
  • Jeffrey S. Montgomery,
  • Keith J. Kowalczyk,
  • Ashley E. Ross,
  • Shilajit D. Kundu,
  • Hiten D. Patel,
  • Gerald J. Wang,
  • John N. Graham,
  • Jonathan E. Shoag,
  • Ahmed Ghazi,
  • Nirmish Singla,
  • Michael A. Gorin,
  • Anthony J. Schaeffer,
  • Edward M. Schaeffer

Background and objective

The transrectal biopsy approach is traditionally used to detect prostate cancer. An alternative transperineal approach is historically performed under general anesthesia, but recent advances enable transperineal biopsy to be performed under local anesthesia. We sought to compare infectious complications of transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis.


We assigned biopsy-naïve participants to undergo transperineal biopsy without antibiotic prophylaxis versus transrectal biopsy with targeted prophylaxis (rectal culture screening for fluoroquinolone-resistant bacteria and antibiotic targeting to culture and sensitivity results) through a multicenter, randomized trial. The primary outcome was post-biopsy infection captured by a prospective medical review and patient report on a 7-d survey. The secondary outcomes included cancer detection, noninfectious complications, and a numerical rating scale (0–10) for biopsy-related pain and discomfort during and 7-d after biopsy.

Key findings and limitations

A total of 658 participants were randomized, with zero transperineal versus four (1.4%) transrectal biopsy infections (difference –1.4%; 95% confidence interval [CI] –3.2%, 0.3%; p = 0.059). The rates of other complications were very low and similar. Importantly, detection of clinically significant cancer was similar (53% transperineal vs 50% transrectal, adjusted difference 2.0%; 95% CI –6.0, 10). Participants in the transperineal arm experienced worse periprocedural pain (0.6 adjusted difference [0–10 scale], 95% CI 0.2, 0.9), but the effect was small and resolved by 7-d.

Conclusions and clinical implications

Office-based transperineal biopsy is tolerable, does not compromise cancer detection, and did not result in infectious complications. Transrectal biopsy with targeted prophylaxis achieved similar infection rates, but requires rectal cultures and careful attention to antibiotic selection and administration. Consideration of these factors and antibiotic stewardship should guide clinical decision-making.

Commentary by Dr. Giancarlo Marra

Transperineal prostate biopsy is recommended by the EAU Guidelines as the preferred approach due to the lower risk of infectious complications. A growing body of non-randomized evidence supports this route increasingly displacing the longstanding mainstay – transrectal biopsy – to the diagnostic outskirts.   


The PReclude infection EVEnts with No prophylaxis Transperineal (PREVENT) randomizsed controlled trial was carried out in multiple institutions in the US. The primary outcome was to evaluate whether the transperineal route is superior compared to the transrectal route in terms of infectious complications. More than 500 biopsy naïve patients were included [1].


Results showed no major differences in terms of infections (-1.4% (n=4 patients for transrectal versus n=0 patients for transperineal biopsies, p=0.059). No cases of sepsis were recorded. Clinically significant cancers have been detected at the same rate, while postprocedural pain was slightly higher in the transperineal group up to day 7.


When interpreting the trial results some aspects have to be kept in mind. Transperineal biopsies were performed without antibiotics whereas transrectal biopsies were carried out with targeted prophylaxis based on rectal culture. Sample size estimation was based on an attended 5% infection in the transrectal biopsy arm and 0.4% in the transperineal arm.


Another recent randomised trial also comparing transperineal biopsies without antibiotics versus transrectal biopsies with antibiotics supports PREVENT results, showing absence of major infectious differences between the two approaches [2].


Overall, infections following transrectal biopsies are likely lower than expected [3], with sepsis being a very rare scenario, not reported in the study.


Not using antibiotics through the transperineal route does not increase infections and remains attractive compared to transrectal biopsies.


Results of the PERFECT [4] and TRANSLATE [5] trials, two randomised trials comparing ISUP 2 PCa detection of transperineal versus transrectal biopsies are eagerly awaited to add additional evidence on the subject.




  1. Hu JC, Assel M, Allaf ME, Ehdaie B, Vickers AJ, Cohen AJ, et al. Transperineal Versus Transrectal Magnetic Resonance Imaging – targeted and Systematic Prostate Biopsy to Prevent Infectious Complications : The PREVENT Randomized Trial. Eur Urol 2024:1–8. doi:10.1016/j.eururo.2023.12.015.
  2. Mian BM, Feustel PJ, Aziz A, Kaufman RP, Bernstein A, Avulova S, et al. Complications Following Transrectal and Transperineal Prostate Biopsy: Results of the ProBE-PC Randomized Clinical Trial. J Urol 2023;211:205–13. doi:10.1097/ju.0000000000003788.
  3. Grummet JP, Weerakoon M, Huang S, Lawrentschuk N, Frydenberg M, Moon DA, et al. Sepsis and “superbugs”: Should we favour the transperineal over the transrectal approach for prostate biopsy? BJU Int 2014;114:384–8. doi:10.1111/bju.12536.
  4. Touzani A, Fiard G, Barret E, Renard-Penna R, Salin A, Pradère B, et al. Clinical Trial Protocol for PERFECT: A Randomised Controlled Trial Comparing the Efficiency and Tolerance of Transperineal Fusion Versus Transrectal Imaging-targeted Prostate Biopsies (CCAFU-PR1 Study). Eur Urol Open Sci 2022;45:76–80. doi:10.1016/j.euros.2022.09.007.
  5. Bryant RJ, Yamamoto H, Eddy B, Kommu S, Narahari K, Omer A, et al. Protocol for the TRANSLATE prospective, multicentre, randomised clinical trial of prostate biopsy technique. BJU Int 2023;131:694–704. doi:10.1111/bju.15978.