Diagnostic yield and cost of three-level H&E sectioning in prostate biopsies
Clinical Snapshot
PICO Framework
| P — Population | Adult males undergoing prostate biopsy at a single academic medical centre (Beth Israel Deaconess Medical Center, Boston, USA), 2015–2022, including both systematic 12-core and combined systematic plus mpMRI-targeted biopsy cohorts |
| I — Intervention | Three-level haematoxylin and eosin (H&E) sectioning protocol applied to prostate biopsy tissue blocks, with additional digital pathology and AI workflow cost estimation |
| C — Comparator | Two-level H&E sectioning protocol (implied comparator); systematic 12-core biopsies compared with combined systematic plus mpMRI-targeted biopsies across the study period |
| O — Outcomes | Primary: incremental diagnostic yield of third-level H&E sections (additional carcinomas detected exclusively on level 3); Secondary: cost per additional diagnosis, total slide volume, workload burden, and estimated digital pathology/AI integration costs per slide |
Bottom Line
This retrospective single-institution study from a US academic centre challenges the routine use of three-level H&E sectioning in combined systematic plus mpMRI-targeted prostate biopsies. The key finding — that third-level sectioning in combined biopsies identified only two additional carcinomas, both Grade Group 1, at a cost of $27,657 per diagnosis — raises legitimate questions about the cost-effectiveness of this protocol in the mpMRI era. The 39% increase in slide volume relative to a 27% increase in case volume underscores the compounding workload burden as digital pathology and AI integration costs are added. However, the study's single-centre retrospective design, absence of statistical precision estimates, uncontrolled temporal confounding, and lack of patient-level clinical data substantially limit confidence in these findings. All additional carcinomas detected exclusively on third-level sections were Grade Group 1, suggesting minimal impact on clinically significant cancer detection — a reassuring finding, but one requiring prospective multi-centre validation before protocol changes are adopted. For Australian pathology laboratories, the directional signal is worth noting, but protocol revision should await RCPA guidance, multi-site validation, and local cost modelling. A prospective study with pre-specified selective third-level criteria and patient-level risk stratification is needed.
Key Findings
P Value: Not reported
Effect Size: Case volume increased 27% over 7 years; tissue blocks and H&E slides increased 39% with adoption of combined protocols. Incremental diagnostic yield of third-level sectioning in combined biopsies was very low (2 additional diagnoses from the combined cohort).
Primary Outcome: In combined systematic plus mpMRI-targeted biopsies, third-level H&E sectioning identified 2 additional carcinomas exclusively on the third level, both Grade Group 1 (clinically low-risk). In systematic 12-core biopsies, 4 additional low-volume carcinomas were identified on third-level sectioning.
Nnt Or Sensitivity: Cost per additional diagnosis on third-level sectioning: $2,283 (systematic 12-core biopsies); $27,657 (combined systematic plus mpMRI-targeted biopsies). H&E slide cost: $7.18/slide; digital pathology and AI add-on: estimated $4.30–$5.00/slide.
Confidence Interval: Not reported
Clinical Application
A two-level H&E sectioning protocol with selective third-level sectioning is operationally feasible in most pathology laboratories. However, operationalising 'selective' criteria requires prospective validation and clear decision rules (e.g., based on PI-RADS score, core length, or initial section findings). Implementation would require laboratory protocol revision, pathologist consensus, and quality assurance monitoring to ensure no clinically significant carcinomas are missed. In Australia, prostate biopsy pathology is governed by RCPA guidelines and increasingly influenced by the uptake of mpMRI-guided biopsy following the MRI-FIRST, PRECISION, and PROMIS trials. The Medicare Benefits Schedule (MBS) funds prostate biopsy histopathology (MBS item 72836 and related), and laboratory processing costs are embedded within institutional funding models. The Royal College of Pathologists of Australasia (RCPA) has not yet issued specific guidance on sectioning level protocols for mpMRI-targeted biopsies. Australian public hospital pathology laboratories facing increasing biopsy volumes and digital pathology infrastructure investment (supported by state health department digital pathology programs) would find the cost-yield framing directly relevant. However, US per-slide cost figures ($7.18) are not directly transferable to Australian MBS or state-funded laboratory cost structures. TGA regulation of AI-based digital pathology tools (as Software as a Medical Device, SaMD) adds a regulatory layer not addressed in this study. RACGP and Urological Society of Australia and New Zealand (USANZ) guidelines on prostate cancer detection should inform any protocol change decisions. Males undergoing prostate biopsy in centres utilising combined systematic and mpMRI-targeted biopsy protocols, particularly in high-volume academic or tertiary pathology laboratories managing increasing digital pathology workloads
Abstract
AIM: The traditional three-level H&E sectioning protocol for prostate biopsies was developed for ultrasound-guided systematic sampling and predates lesion-targeted biopsy approaches. Multiparametrical MRI (mpMRI) has improved detection of clinically significant prostate carcinoma but has also increased biopsy volume, workload, costs and digital pathology requirements, including whole-slide imaging and artificial intelligence (AI) integration. METHODS AND RESULTS: A retrospective institutional cost-yield analysis was performed on prostate biopsy cases at Beth Israel Deaconess Medical Center (2015-2022), comparing systematic 12-core biopsies with combined systematic and mpMRI-targeted biopsies. Case volume, tissue blocks and H&E slides were analysed. Per-slide costs were calculated, and additional digital pathology and AI workflow costs were estimated using published data and vendor pricing. Case volume increased by 27% over 7 years, while combined systematic and mpMRI-targeted protocols increased tissue blocks and H&E slides by 39%. The cost per H&E slide was $7.18, with digital pathology and AI workflows adding an estimated $4.30-5.00 per slide. In systematic 12-core biopsies, third-level sectioning identified four additional low-volume carcinomas at a cost of $2283 per diagnosis. In combined biopsies, two additional carcinomas were detected exclusively on the third level, both Grade Group 1, with a cost of $27 657 per diagnosis. CONCLUSION: Routine three-level H&E sectioning in combined systematic and mpMRI-targeted prostate biopsies demonstrated low incremental diagnostic yield and substantial additional processing cost. A two-level protocol with selective third-level sectioning may preserve detection of clinically significant carcinomas in this institutional cohort, while reducing workload and cost in the digital pathology era.
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