Abstract
Background
Multiparametric magnetic resonance imaging (MRI)-targeted biopsy has improved prostate cancer detection, yet the relative diagnostic contributions of MRI-fusion-targeted biopsy and systematic transrectal ultrasound-guided (TRUS) biopsy across prostate-specific antigen (PSA) and PSA density (PSAD) levels remain uncertain. We evaluated the incremental detection of clinically significant prostate cancer (csPCa) between these techniques.
Methods
This retrospective single-center paired cohort study included 376 men with biopsy-proven prostate cancer who underwent both MRI fusion-targeted and 12-core systematic TRUS biopsy in the same session for a Prostate Imaging Reporting and Data System ≥3 lesion. csPCa was defined as International Society of Urological Pathology Grade Group ≥2. Detection was compared overall and across PSA strata (<4, 4–10, 10.01–20, 20.01–50, >50 ng/mL) and PSAD groups (<0.10, 0.10–<0.15, ≥0.15 ng/mL/cc) using exact McNemar testing on discordant pairs.
Results
Overall prostate cancer detection was similar between MRI fusion-targeted and systematic TRUS biopsy (318/376, 84.6% vs. 316/376, 84.0%; P = 0.927). csPCa was detected in 226/376 patients (60.1%) by MRI fusion-targeted biopsy and 212/376 (56.4%) by systematic biopsy; 60 MRI-only and 46 systematic-only discordant cases were observed (P = 0.206). MRI fusion-targeted biopsy showed numerically higher csPCa detection across the intermediate PSA range (4–50 ng/mL), with the largest absolute difference of 9.1 percentage points at PSA 20.01–50 ng/mL (n = 33); no PSA-stratified comparison reached statistical significance. csPCa detection increased with PSAD for both techniques across all three PSAD strata.
Conclusion
MRI fusion-targeted and systematic TRUS biopsies were complementary for csPCa detection. MRI fusion-targeted biopsy showed a numerical advantage in the intermediate PSA range, while csPCa detection increased with PSA density for both techniques. These findings support risk-stratified interpretation of biopsy yield and do not support routine omission of systematic cores when MRI-fusion-targeted biopsy is performed.
Keywords: Clinically significant prostate cancer, Magnetic resonance imaging-targeted biopsy, Prostate cancer, Prostate-specific antigen density, Systematic transrectal ultrasound-guided biopsy
1. Introduction
Prostate cancer is one of the most common malignancies among men worldwide, and early detection of clinically significant prostate cancer (csPCa), typically defined as International Society of Urological Pathology (ISUP) Grade Group ≥2, is essential for optimizing treatment outcomes while minimizing overtreatment of indolent disease.1,2
Multiparametric magnetic resonance imaging (mpMRI) has substantially improved prostate cancer detection and risk stratification. MRI-targeted biopsy has demonstrated improved detection of clinically significant cancers and reduced identification of clinically insignificant tumors compared with systematic biopsy alone in landmark trials and meta-analyses.3,4 Contemporary European Association of Urology (EAU) and American Urological Association/Society of Urologic Oncology (AUA/SUO) guidance supports MRI-based diagnostic pathways before biopsy when feasible.1,2
Despite these advances, MRI-targeted biopsy does not detect all clinically significant cancers. False-negative MRI results occur with small, low-contrast, or transition-zone tumors, and even visible lesions may be undersampled.5 Large paired-biopsy studies have shown that combining targeted and systematic biopsies improves overall csPCa detection compared with either technique alone.6,7 Recent Asian cohort studies also suggest that a low Prostate Imaging Reporting and Data System (PI-RADS) score or MRI-negative status does not exclude clinically significant prostate cancer.8, 9, 10
An important unresolved question is how patient risk factors, particularly prostate-specific antigen (PSA) and PSA density (PSAD), influence the relative diagnostic contribution of MRI-targeted and systematic biopsy techniques. PSA remains a central trigger for biopsy, and PSAD has emerged as an important predictor of csPCa and a useful triage parameter within MRI-based evaluation.1,2
Therefore, this study aimed to evaluate the detection of csPCa using paired MRI fusion-targeted and systematic transrectal ultrasound-guided (TRUS) biopsies performed in the same session, with particular focus on how PSA and PSAD influence the relative diagnostic yield of these techniques.
2. Materials and methods
2.1. Study design and setting
This retrospective single-center study was conducted at Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. Clinical, imaging, and pathological data were obtained from the hospital's electronic medical record and pathology database for men who underwent prostate biopsy between January 1, 2014, and August 31, 2024.
2.2. Study population
During the study period, 1,313 men underwent prostate biopsy at our institution. Patients were eligible if they underwent both MRI fusion-targeted and 12-core systematic TRUS biopsies in the same session for an mpMRI-detected PI-RADS ≥3 lesion, had a prebiopsy prostate mpMRI at Ramathibodi Hospital, had a documented serum PSA level before MRI, and had complete pathology data, including histologic type and Gleason score/ISUP Grade Group. Patients were excluded if only one technique was used, if the systematic biopsy was incomplete (<12 cores), if essential diagnostic data were missing, or if the highest documented MRI lesion was PI-RADS 2, which did not qualify for targeted biopsy under the institutional protocol. Five such patients were identified during source-record rereview and were excluded according to these predefined eligibility criteria. Because the analytic objective was to compare paired biopsy yield within men with prostate cancer detected by at least one method, the final analytic cohort was restricted to patients with biopsy-proven prostate cancer. Detection rates, therefore, reflect within-cancer technique agreement and should not be interpreted as detection rates in an unselected, biopsy-naïve, or MRI-screened population. Negative predictive value cannot be calculated from this design. After applying these criteria, 376 men comprised the final analytic cohort.
Prebiopsy serum PSA was available for all 376 patients. Age was available for 374 patients (two missing values), and prostate volume and PSAD were available for 373 patients (three missing prostate-volume measurements). These denominators are reflected in Table 1.
Table 1.
Baseline characteristics of the study cohort
| Variable | Value | Available n |
|---|---|---|
| Age, years (mean ± SD) | 74.2 ± 7.0 | 374 |
| PSA, ng/mL (median, IQR) | 8.6 (6.1–13.3) | 376 |
| PSA <4 ng/mL | 16 (4.3%) | 376 |
| PSA 4–10 ng/mL | 220 (58.5%) | 376 |
| PSA 10.01–20 ng/mL | 99 (26.3%) | 376 |
| PSA 20.01–50 ng/mL | 33 (8.8%) | 376 |
| PSA >50 ng/mL | 8 (2.1%) | 376 |
| Number of MRI lesions per patient | 375 | |
| 1 lesion | 313 (83.5%) | |
| 2 lesions | 54 (14.4%) | |
| 3 lesions | 8 (2.1%) | |
| PI-RADS score (lesion-level, 445 lesions) | ||
| PI-RADS 3 | 48 (10.8%) | |
| PI-RADS 4 | 216 (48.5%) | |
| PI-RADS 5 | 181 (40.7%) | |
| Prostate volume, cc (mean ± SD) | 38.7 ± 20.7 | 373 |
| PSA density, ng/mL/cc (median, IQR) | 0.26 (0.16–0.43) | 373 |
Denominators vary by variable owing to missing data, as indicated in the “Available n” column. IQR, interquartile range; MRI, magnetic resonance imaging; PI-RADS, Prostate Imaging Reporting and Data System; PSA, prostate-specific antigen; SD, standard deviation.
2.3. PSA and PSAD stratification
Serum PSA was measured within three months of the biopsy using standard institutional assays. Patients were stratified into five PSA groups: <4, 4–10, 10.01–20, 20.01–50, and >50 ng/mL. PSAD was calculated as serum PSA divided by prostate volume measured on MRI. PSAD-stratified analyses used the clinically established categories <0.10, 0.10–<0.15, and ≥0.15 ng/mL/cc, consistent with current EAU and AUA/SUO frameworks.1,2
2.4. MRI acquisition and interpretation
All patients underwent prostate mpMRI using a standardized institutional protocol including T2-weighted imaging in three planes, diffusion-weighted imaging with apparent diffusion coefficient maps, and dynamic contrast-enhanced sequences. Examinations were interpreted by experienced genitourinary radiologists and reported using PI-RADS version 2 or later. The highest PI-RADS score, number of suspicious lesions, lesion location, and prostate volume were recorded. Lesions with PI-RADS ≥3 were considered suspicious and targeted for biopsy; the institutional protocol does not include targeted biopsy for PI-RADS 1–2 lesions.
2.5. Biopsy technique and pathology assessment
All biopsies were performed in a single session under transrectal ultrasound guidance with an MRI–ultrasound fusion system. Each PI-RADS ≥3 lesion underwent MRI fusion-targeted biopsy with at least two cores per lesion, followed by a ≥12-core systematic TRUS biopsy using an extended template. Both components were performed by the same operator with knowledge of the MRI findings; operator blinding during systematic sampling was not feasible in this real-world combined-biopsy workflow. Specimens were graded using the ISUP Grade Group system. csPCa was defined as ISUP Grade Group ≥2 (Gleason score ≥3 + 4).
2.6. Outcomes
The primary outcome was detection of csPCa by MRI fusion-targeted versus systematic TRUS biopsy, evaluated overall and across PSA strata. Secondary outcomes included overall prostate cancer detection, cross-classification of csPCa detection, and PSAD-stratified csPCa detection. An additional sensitivity analysis used ISUP Grade Group ≥3 as the csPCa threshold. An exploratory characterization of systematic-only csPCa cases examined prostate volume, lesion location, and PI-RADS distribution.
2.7. Statistical analysis
Categorical variables were reported as counts (percentages) and continuous variables as mean ± SD or median (interquartile range [IQR]). Paired comparisons were conducted using exact McNemar's test. Two-sided 95% confidence intervals for proportions were calculated using the Wilson score method. A two-sided P-value <0.05 was considered statistically significant. Analyses were performed using STATA (StataCorp, College Station, TX, USA).
3. Results
3.1. Patient and MRI characteristics
The study included 376 men who underwent both MRI fusion-targeted and systematic TRUS biopsies in the same session for a PI-RADS ≥3 lesion. The mean age was 74.2 ± 7.0 years. The median PSA was 8.6 ng/mL (IQR: 6.1–13.3). A single suspicious lesion was present in 83.5% of patients with recorded lesion data (n = 375). PI-RADS 4 and 5 lesions together comprised 89.2% of all 445 suspicious lesions. Baseline characteristics are summarized in Table 1.
3.2. Overall cancer detection and paired comparison
Prostate cancer detection was similar between MRI fusion-targeted biopsy and systematic TRUS biopsy: 318/376 (84.6%, 95% confidence interval [CI]: 80.6–87.9) and 316/376 (84.0%, 95% CI: 80.0–87.4), respectively. Cross-classification showed 258 patients positive by both methods, 60 positive only by MRI fusion-targeted biopsy, 58 positive only by systematic TRUS biopsy, and 0 negative by both (P = 0.927).
For csPCa, MRI fusion-targeted biopsy detected 226/376 patients (60.1%, 95% CI: 55.1–64.9) and systematic TRUS biopsy detected 212/376 (56.4%, 95% CI: 51.3–61.3). Cross-classification showed 166 patients positive by both methods, 104 negative by both, 60 positive only by MRI fusion-targeted biopsy, and 46 positive only by systematic TRUS biopsy (exact McNemar P = 0.206). Results are summarized in Table 2.
Table 2.
Paired detection results for any prostate cancer and clinically significant prostate cancer.
| Outcome | MRI+/Sys+ | MRI+/Sys− | MRI−/Sys+ | MRI−/Sys− | Exact McNemar P |
|---|---|---|---|---|---|
| Any prostate cancer | 258 | 60 | 58 | 0 | 0.927 |
| Clinically significant prostate cancer (ISUP ≥2) | 166 | 60 | 46 | 104 | 0.206 |
Exact McNemar P values were calculated from discordant pairs. csPCa was defined as ISUP Grade Group ≥2 (Gleason score ≥3 + 4). The any-prostate-cancer MRI−/Sys− cell is zero because the analytic cohort was restricted to men with biopsy-proven prostate cancer.ISUP, International Society of Urological Pathology; MRI, magnetic resonance imaging fusion-targeted biopsy; Sys, systematic TRUS biopsy.
3.3. Exploratory characterization of systematic-only csPCa cases
In an exploratory characterization of the 46 patients in whom csPCa was detected only by systematic TRUS biopsy, prostate volume was similar to that of the 226 MRI-detected csPCa cases (median 32.8 cc vs. 33.0 cc; mean 39.0 ± 22.9 cc vs. 37.8 ± 19.0 cc). MRI lesions in these patients were predominantly posterior peripheral-zone (38/50 lesions, 76.0%, vs. 57.7% in the full cohort) rather than anterior or transition-zone (8/50, 16.0%, vs. 26.4% in the full cohort), and most were high-suspicion (PI-RADS 4: 62.0%; PI-RADS 5: 26.0%). PSA and PSAD medians appeared broadly similar between groups on descriptive review.
3.4. PSA-stratified csPCa detection
Across PSA strata, csPCa detection tended to increase with higher PSA for both techniques, though estimates at the PSA extremes (n = 16 for <4 ng/mL; n = 8 for >50 ng/mL) were limited by small subgroup sizes. The largest absolute between-technique difference (+9.1 percentage points at PSA 20.01–50 ng/mL, n = 33) is best regarded as a stochastic numeric pattern given the small subgroup size and nonsignificant comparison (P = 0.453). No PSA-stratified comparison reached statistical significance (Table 3).
Table 3.
Clinically significant prostate cancer detection by PSA stratum.
| PSA stratum (ng/mL) | Systematic TRUS | MRI fusion-targeted | Absolute difference | Exact McNemar P |
|---|---|---|---|---|
| <4 (n = 16) | 8/16 (50.0%) | 7/16 (43.8%) | −6.2 | 1.000 |
| 4–10 (n = 220) | 118/220 (53.6%) | 125/220 (56.8%) | +3.2 | 0.477 |
| 10.01–20 (n = 99) | 59/99 (59.6%) | 65/99 (65.7%) | +6.1 | 0.327 |
| 20.01–50 (n = 33) | 20/33 (60.6%) | 23/33 (69.7%) | +9.1 | 0.453 |
| >50 (n = 8) | 7/8 (87.5%) | 6/8 (75.0%) | −12.5 | 1.000 |
Absolute difference is reported in percentage points (MRI fusion-targeted minus systematic TRUS). MRI, magnetic resonance imaging; PSA, prostate-specific antigen; TRUS. transrectal ultrasound-guided.
3.5. PSAD-stratified csPCa detection
PSAD data were available for 373 patients. csPCa detection increased with higher PSAD for both techniques. MRI fusion-targeted biopsy showed a small numerical advantage at each PSAD level (absolute differences of 4.2, 5.5, and 3.7 percentage points at PSAD <0.10, 0.10–<0.15, and ≥0.15 ng/mL/cc, respectively), but none of the paired comparisons reached statistical significance (Table 4).
Table 4.
Clinically significant prostate cancer detection by PSA density.
| PSAD group (ng/mL/cc) | Systematic TRUS | MRI fusion-targeted | Absolute difference | Exact McNemar P |
|---|---|---|---|---|
| <0.10 (n = 24) | 7/24 (29.2%) | 8/24 (33.3%) | +4.2 | 1.000 |
| 0.10–<0.15 (n = 55) | 28/55 (50.9%) | 31/55 (56.4%) | +5.5 | 0.549 |
| ≥0.15 (n = 294) | 175/294 (59.5%) | 186/294 (63.3%) | +3.7 | 0.278 |
Absolute difference is reported in percentage points (MRI fusion-targeted minus systematic TRUS). Three patients were excluded from the PSA-density analysis owing to missing prostate-volume measurements.
MRI, magnetic resonance imaging; PSAD, prostate-specific antigen density; TRUS, transrectal ultrasound-guided.
3.6. Sensitivity analysis at ISUP Grade Group ≥3
In an additional sensitivity analysis using ISUP Grade Group ≥3 as the csPCa threshold, MRI fusion-targeted biopsy detected disease in 127/376 patients (33.8%) and systematic TRUS biopsy in 125/376 (33.2%), with 32 MRI-only and 30 systematic-only discordant cases (exact McNemar P = 0.899). The complementarity pattern was preserved, and the absolute between-technique difference was numerically smaller at the higher grade threshold.
4. Discussion
In this paired cohort of 376 men, overall prostate cancer and csPCa detection were broadly similar between MRI fusion-targeted and systematic TRUS biopsy. The principal observation was complementarity rather than superiority: MRI fusion-targeted biopsy identified 60 csPCa cases missed by systematic sampling, while systematic TRUS biopsy detected 46 additional csPCa cases not captured by targeted cores.
This pattern aligns with prior paired-biopsy studies showing that neither technique alone captures all clinically significant cancers.3,4,6,7 Our data contribute to this literature by characterizing how the relative yield varies across PSA and PSAD strata in a real-world Asian cohort, an increasingly recognized, underrepresented setting in MRI-based diagnostic pathway research 8, 9, 10.
Across PSA strata, csPCa detection tended to increase with higher PSA for both techniques, though estimates at the PSA extremes (n = 16 for <4 ng/mL; n = 8 for >50 ng/mL) were limited by small subgroup sizes. The largest absolute between-technique gap (+9.1 percentage points in the PSA 20.01–50 ng/mL stratum) is best regarded as a stochastic numeric pattern given the small subgroup size (n = 33) and a paired exact McNemar P value of 0.453. All stratified comparisons are therefore presented descriptively.
Both techniques showed higher csPCa detection rates with increasing PSA density, consistent with contemporary MRI-based pathways incorporating PSAD for risk stratification.1,2 The absolute advantage of MRI fusion-targeted biopsy across PSAD strata was modest (3.7–5.5 percentage points), and none of the paired comparisons reached statistical significance. These findings are exploratory and hypothesis-generating, supporting risk-adapted combined sampling rather than selective omission of systematic cores.
Our exploratory characterization of the 46 systematic-only csPCa cases did not support the hypotheses that these cases reflected occult transition-zone disease or detection facilitated by larger prostate volume. Prostate volume was essentially identical to that of MRI-detected csPCa cases, lesion locations were predominantly posterior peripheral-zone, and most lesions were high-suspicion on MRI (PI-RADS 4–5). This pattern may be more consistent with intra- or peri-lesional spatial sampling than with radiologically occult disease, and we do not propose criteria for safe omission of systematic biopsy in this cohort.
In an additional sensitivity analysis using ISUP Grade Group ≥3, the complementarity pattern was preserved (MRI fusion-targeted 33.8% vs. systematic 33.2%; exact McNemar P = 0.899), with a numerically smaller absolute difference than at the primary ISUP ≥2 threshold. The qualitative finding of complementarity was consistent across both csPCa definitions.
From a practical standpoint, these findings support a complementary, risk-adapted diagnostic approach. Our data—along with prior paired-biopsy evidence6,7—suggest that omitting systematic cores may underestimate csPCa, particularly in cohorts with the case mix and lesion characteristics described here.
This study has several limitations. First, it was retrospective and single-center. Second, the analytic cohort comprised only men with biopsy-proven prostate cancer; the cohort disease prevalence is structurally inflated relative to a biopsy-naïve pathway, and negative predictive value cannot be estimated from this design. Third, subgroup analyses at PSA extremes and PSAD <0.10 ng/mL/cc included few patients. Fourth, all biopsies were performed transrectally; results may differ with transperineal biopsy.11 Fifth, MRI examinations were not centrally re-reviewed. Sixth, the study period spanned 2014–2024; temporal evolution in MRI hardware, PI-RADS reporting versions, and operator experience may have influenced results, and a learning-curve effect cannot be excluded. A formal temporal-trend analysis was neither prespecified nor performed. Seventh, the systematic-biopsy operator was not blinded to MRI findings, in contrast to dedicated dual-operator paired-biopsy designs such as MRI-FIRST;12 however, the bidirectional discordance pattern (46 systematic-only vs. 60 MRI-only csPCa cases) supports the interpretation that the two techniques sampled complementary tissue rather than duplicating the same targets.
The study's principal strength is the paired same-session design, which enables direct within-patient comparison of diagnostic yield while minimizing confounding by patient selection, disease prevalence, and temporal change.
5. Conclusion
In men undergoing simultaneous MRI fusion-targeted and systematic TRUS biopsy, overall prostate cancer and csPCa detection rates were similar between techniques, but each method identified clinically significant tumors missed by the other. MRI fusion-targeted biopsy showed a numerical advantage in the intermediate PSA range, while csPCa detection increased with PSA density for both techniques. These findings support a complementary role for both biopsy methods and do not support routine omission of systematic cores when MRI fusion-targeted biopsy is performed.
Author contributions
Conceptualization: T.V., W.V.; Data curation: T.V.; Formal analysis: T.V.; Investigation: T.V.; Methodology: T.V., W.V.; Supervision: W.V.; Writing – original draft: T.V.; Writing – review and editing: T.V., W.V. All authors have read and approved the final version of the manuscript.
Ethics statement
This retrospective study was conducted in accordance with the Declaration of Helsinki and was approved by the Human Research Ethics Committee of the Faculty of Medicine Ramathibodi Hospital, Mahidol University (COA No. MURA2024/705; initial approval 7 October 2024; renewal Ref. 2025/1137 dated 7 October 2025). Because of the retrospective design and analysis of de-identified data, the requirement for informed consent was waived by the Institutional Review Board.
Data availability statement
The de-identified data that support the findings of this study are available from the corresponding author upon reasonable request, subject to institutional and Institutional Review Board approval.
Declaration of generative AI use
During the preparation of this manuscript, the authors used a generative artificial intelligence tool (Anthropic Claude) solely to improve the English language and the text's readability. The authors independently performed all aspects of study design, data collection, data analysis, and interpretation of results, and take full responsibility for the content of the manuscript.
Funding
No external funding was received for this study.
Conflicts of interest
The authors declare no conflicts of interest.
Acknowledgments
The authors express their sincere gratitude to Ms. Suraida Aeesoa, MSc, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, for her assistance with the statistical analysis.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The de-identified data that support the findings of this study are available from the corresponding author upon reasonable request, subject to institutional and Institutional Review Board approval.