Patient-centric outcomes determine the value proposition of prostate biopsy procedures

We read with great interest the commentary by Sordelli et al. (1) on the patient-reported outcomes from our randomized clinical trial (RCT) comparing transrectal (TR) and transperineal (TP) prostate biopsy and are grateful for the opportunity to provide some firsthand perspective (2). The ProBE-PC study was the first large RCT to compare the diagnostic yield and complications following contemporary TR and TP biopsy performed under local anesthesia (3). There were no statistically significant differences noted in infectious and non-infectious complications between TR and TP biopsy. Our findings were subsequently validated by other RCTs including TRANSLATE, PREVENT and PERFECT studies, which also did not demonstrate any significant difference in complications following the two procedures (4-6).

The proposed diagnostic advantage of TP biopsy was estimated to be a 10% higher rate of grade group 2 prostate cancer detection. The ProBE-PC (840 men) and TRANSLATE (1,126 men) studies were specifically powered to demonstrate the superior detection rate with TP biopsy. While the TRANSLATE study demonstrated a statistically significant increase in cancer detection by 5.7% (P=0.03), neither of the RCTs met the proposed diagnostic threshold of 10%. The PERFECT study, with a non-inferiority design in favor of TP, conversely demonstrated a 7% higher cancer detection in favor of TR biopsy.

Previously, access to lesions in the anterior or apical zones via TR route was thought to be limited due to physical constraints and that larger prostates with anterior/apical lesions may be less accessible with TP approach due to interference by the pubic arch. We have not found either the TR route or the TP route to impose any physical constraints in access to these lesions. Further, there is a lack of a consistent, clinically significant diagnostic advantage in randomized studies to either of the two approaches. Both the TRANSLATE and ProBE-PC studies report similar cancer detection rates with TR or TP approach for anterior tumors. The PERFECT study reported a numerical but statistically non-significant advantage to TP for anterior tumors. Interestingly, there was a statistically significant diagnostic advantage to the TR biopsy for posterior tumors (69% vs. 54%, P=0.04). This contradiction is clinically relevant since 75–85% of tumors reside in the posterior prostate.

Patient-reported outcomes are central to the value proposition of any medical intervention. Many authors who favor TP biopsy often characterize the higher pain associated with TP biopsy under local anesthesia as slight and transient. The PROMs from the ProBE-PC study (as well as TRANSLATE and PREVENT studies) demonstrate higher mean and median pain scores after TP biopsy. Additionally, “clinically meaningful” pain scores (validated as pain score ≥4) were several-fold higher during and after TP biopsy than the TR biopsy. Patients also reported noticeably higher pain after TP biopsy on the third day (2). Additionally, “clinically meaningful” worsening [validated as ≥3 point increase in International Prostate Symptom Score (IPSS)] of lower urinary tract symptoms and quality of life was reported more frequently following TP biopsy when measuring symptom scores at 2 weeks (2).

Higher pain scores with TP compared to TR biopsy are not isolated to a single study but represent a common pattern consistently observed across multiple observational studies and RCTs on this topic (4,5,7-9). Although variability in procedural factors is inevitable across different centers, it is noteworthy that these studies were conducted by expert operators and at centers with considerable experience in TP biopsy. The tolerability and acceptance of any procedure is heavily influenced by how the procedure is framed during counseling. If patients are advised that TP biopsy is the superior approach, they are more likely to accept the trade-off between higher levels of pain for some perceived benefit. Contemporary RCTs have confirmed that most TP biopsy can be performed without antibiotic prophylaxis and most TR biopsy only require a single dose of antibiotics. The theoretical advantage of omitting one dose of antibiotics or its effect on patients or population has not been studied.

The TP biopsy approach has long been recognized as a more expensive procedure, with the added cost theoretically being offset by a significant reduction in complications. However, those expectations have not been realized. The health economics reports from both the TRANSLATE and the ProBE-PC studies demonstrate higher cost of TP biopsy under local anesthesia compared to TR biopsy (10,11). The aforementioned cost analyses are for office-based, local anesthetic procedures. The differences in cost become more pronounced when TP biopsy is performed under sedation or general anesthesia.

The comprehensive PROMs report from ProBE-PC, alongside prior findings from the same trial and subsequent randomized studies, consistently demonstrates no distinct safety or diagnostic advantage to either TR or TP approaches. In this context, the patient feedback should not be overlooked and experience associated with prostate biopsy should drive shared decision-making instead of single path for all patients. Patient-centric outcomes, encompassing procedural pain, anxiety, post-biopsy urinary dysfunction and cost, represent precisely the kind of actionable evidence that should shape clinical decision-making and patient counseling.

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-2026-0503/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-2026-0503/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

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