Patient experience and procedural safety in prostate biopsy: interpreting patient-reported outcome measures in the era of transperineal biopsy

Over the past decade, the transperineal (TP) approach became the new standard of care for prostate biopsy, over the traditional transrectal (TR) route. Historically, TR biopsy was the standard approach largely because of its technical simplicity and feasibility in the outpatient setting. However, growing awareness of infectious complications associated with rectal flora contamination has led to renewed interest in TP biopsy as a strategy to mitigate infection risk and reduce antibiotic exposure (1-3). In parallel, recent randomized clinical trials comparing TP and TR biopsy strategies have reported a modest increase in the detection of clinically significant prostate cancer with the TP approach, further supporting its role in contemporary diagnostic pathways (4,5).

The Prostate Biopsy Efficacy and Complications (ProBE-PC) randomized clinical trial was designed to address this evidence gap by directly comparing infectious and non-infectious complications following TR and TP biopsy performed under local anaesthesia in an office setting (6). In the primary analysis of the study, no significant differences were observed between the two approaches regarding infectious or non-infectious complications within 30 days. Composite infectious events occurred in 2.6% of patients undergoing TR biopsy and 2.7% of those undergoing TP biopsy, with no cases of sepsis reported in either group. Non-infectious complications were also uncommon and similar between groups. These results suggest that TP biopsy did not lead to higher post-biopsy infection rates despite the absence of antibiotic prophylaxis, highlighting a potential advantage by reducing antibiotic use, healthcare costs, and environmental impact (7). This has allowed TP biopsy to be performed without antibiotic prophylaxis, with consistently low rates of infectious complications reported in contemporary randomized studies (8). Overall, this approach helps reduce unnecessary antibiotic exposure and its associated risks, while maintaining procedural safety.

While the primary objective of prostate biopsy remains the accurate detection of clinically significant prostate cancer, within the context of comparable safety outcomes, the evaluation of patient-reported outcome measures (PROMs) is particularly important for understanding the broader patient experience associated with prostate biopsy. The secondary analysis of the ProBE-PC trial reported by Waisman Malaret et al. focuses specifically on PROMs, including procedural pain, urinary symptoms, and sexual function following biopsy (9). Procedural pain was assessed using a numerical rating scale [0–10]. Patients undergoing TP biopsy reported higher pain scores during local anaesthetic administration compared with the TR approach (mean score 3.3 vs. 0.7, P<0.001), and slightly higher pain levels on the evening following the procedure (2.0 vs. 1.5, P<0.001). Clinically significant pain (score ≥4) was also more frequent in the TP group, particularly during local anaesthetic injection (37.9% vs. 2.6%). In addition, at 2 weeks after biopsy, a greater worsening of the International Prostate Symptom Score (IPSS) was observed in the TP group compared with the TR group (+1.2 vs. +0.3 points, P=0.002). Clinically significant worsening of urinary symptoms and quality of life was also more frequent after TP biopsy (28% vs. 18%, P=0.009, and 31% vs. 22%, P=0.02), whereas erectile function outcomes appeared similar between the two techniques.

The prospective assessment of patient-reported symptoms at multiple predefined time points represents a strength of the study and provides a detailed description of the patient experience surrounding prostate biopsy. Nevertheless, these findings must be interpreted within the technical and anatomical context of the two biopsy approaches. In particular, the TR approach is inherently constrained by the rectal cavity, which may limit needle manoeuvrability and restrict sampling patterns. In contrast, the TP approach allows more flexible access to the prostate through external trajectories, potentially enabling more comprehensive and tailored sampling and improved procedural efficiency (10).

The observation of increased procedural pain during TP biopsy performed under local anaesthesia is biologically plausible. Unlike the TR route, which involves needle passage through the rectal wall, the TP approach requires infiltration of the perineal skin, subcutaneous tissues, and pelvic floor musculature prior to biopsy needle insertion. These structures are richly innervated by somatic sensory fibres, and anaesthetic infiltration itself may therefore be associated with transient discomfort. Moreover, repeated needle passage through the pelvic floor muscles may contribute to short-term pelvic floor irritation, potentially explaining the temporary worsening of urinary symptoms observed after TP biopsy.

These observations are consistent with previous studies evaluating patient-reported outcomes following TP biopsy performed under local anaesthesia. Marra et al. reported moderate procedural pain during TP biopsy performed under local anaesthesia (mean pain score 3.9 during anaesthetic administration and 3.1 during biopsy), although most patients considered the procedure tolerable and acceptable. Interestingly, patient anxiety was identified as an important predictor of severe procedural pain (11). Similarly, prospective observational studies have demonstrated that patients undergoing TP biopsy frequently report manageable levels of procedural pain and remain willing to undergo repeat biopsy if clinically indicated (12,13). Taken together, these findings suggest that although TP biopsy may be associated with greater procedural discomfort under local anaesthesia, the overall tolerability of the procedure remains acceptable in routine practice.

Importantly, differences in patient-reported pain should also be interpreted considering potentially modifiable procedural factors. Procedural pain may be influenced by several technical factors, including anaesthetic infiltration techniques, injection volumes, waiting time before needle insertion, operator experience, as well as the type of local anaesthesia (periprostatic vs. apical block) and the biopsy technique itself (freehand vs. fixed TP approaches). As the adoption of TP biopsy continues to expand, further refinement of anaesthetic protocols, including optimized local infiltration techniques, tumescent anaesthesia, or selective use of nerve blocks, may contribute to improving the patient experience.

Beyond considerations related to procedural discomfort, the TP approach offers several diagnostic advantages that have contributed to its increasing adoption in modern prostate cancer diagnostic pathways. Access through the perineum allows more reliable sampling of the anterior and apical regions of the prostate, which may be difficult to reach with the TR approach and therefore at risk of under-sampling (8). In magnetic resonance imaging (MRI)-guided prostate cancer diagnostics, the TP approach also allows easier targeting of anterior lesions identified on imaging and provides more flexible access to the prostate, which may facilitate more comprehensive and tailored sampling, reduce procedure time, and ultimately improve patient experience. More broadly, the choice of imaging modality represents an additional key factor in prostate biopsy, as ultrasound- and multiparametric MRI (mpMRI)-guided approaches differ in terms of lesion visualization and targeting accuracy, with potential implications for diagnostic performance and patient experience (14).

Recent clinical studies have further highlighted the potential diagnostic benefits of TP biopsy strategies. In particular, lesion-focused TP biopsy strategies combining targeted and perilesional sampling have been associated with improved detection of clinically significant prostate cancer while reducing the diagnosis of indolent disease (15).

In this context, the results of this PROM analysis should not be seen as challenging the shift toward TP prostate biopsy. Rather, they underline the importance of improving the technique to increase patient comfort while keeping its diagnostic advantages. In MRI-guided diagnostic pathways, TP biopsy may offer anatomical and technical advantages that allow more precise targeting of suspicious lesions. Patient-reported outcomes provide important information about the patient experience after diagnostic procedures. Traditional clinical endpoints, such as complication rates and cancer detection, remain important measures of procedural success. However, they do not fully reflect the patient experience after procedures such as prostate biopsy. PROM analyses therefore provide useful information that may help improve procedural techniques, patient counselling, and shared decision-making. Ultimately, the ProBE-PC trial and its PROM analysis provide important insights into both the safety and patient experience of contemporary prostate biopsy techniques. While both TR and TP approaches show low infection rates, the TP approach avoids the need for antibiotic prophylaxis. Future efforts will likely focus on refining TP techniques to improve diagnostic accuracy while maintaining patient comfort.

In conclusion, TP biopsy combines diagnostic advantages with low infection risk and acceptable tolerability, supporting its role as the preferred approach in contemporary practice.

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-2026-0247/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tau.amegroups.com/article/view/10.21037/tau-2026-0247/coif). The authors have no conflicts of interest to declare.

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