Prospective Comparison of Cognitive MRI-Targeted Biopsy Under Micro-Ultrasound Guidance Versus MRI/Ultrasound Fusion-Guided Transperineal Biopsy for Clinically Significant Prostate Cancer Detection
6 affiliations
- 1Department of Urology, San Giuseppe Moscati Hospital, 81031 Aversa, Italy
- 2Department of Urology, La Sapienza University, 00185 Rome, Italy
- 3Department of Urology, Fundació Puigvert, 08025 Barcelona, Spain
- 4Urology Unit, Department of Surgery, Dentistry, Pediatrics and Gynecology, Azienda Ospedaliera Universitaria Integrata, University of Verona, 37126 Verona, Italy
- 5Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy
- 6Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples “Federico II”, 80131 Naples, Italy
Abstract
Background/Objectives: Multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy has become central to prostate cancer (PCa) diagnosis. While cognitive and software-based fusion targeting have already been compared, the use of high-resolution micro-ultrasound as a real-time guidance platform for cognitive translation of MRI-defined lesions remains incompletely characterized. This study prospectively compared mpMRI-transrectal ultrasound (TRUS) fusion-guided transperineal (TP) biopsy with cognitive MRI-targeted TP biopsy under real-time ExactVu® micro-ultrasound guidance. Methods: We conducted a prospective, observational, comparative study including 58 consecutive patients with suspected PCa and at least one lesion on pre-biopsy mpMRI with a Prostate Imaging Reporting and Data System (PI-RADS) score ≥ 3. Twenty-nine patients were included in each group. The analysis used a standardized 16-core TP biopsy set comprising four targeted cores from the MRI-defined index lesion and 12 systematic cores. The primary endpoint was clinically significant PCa (csPCa) detection, defined as International Society of Urological Pathology (ISUP) Grade Group (GG) ≥ 2. Results: Overall, PCa detection was 65.5% in the fusion-guided biopsy group and 55.2% in the cognitive MRI-targeted biopsy group (absolute risk difference, 10.3 percentage points; 95% CI, −14.1 to 33.2; p = 0.592). csPCa detection was identical in the two groups (37.9% each; absolute risk difference, 0.0 percentage points; 95% CI, −23.6 to 23.6; p = 1.000). In exploratory multivariable logistic regression, biopsy technique was not associated with csPCa detection after adjustment (adjusted OR 0.73, 95% CI 0.22–2.40; p = 0.605), whereas prostate-specific antigen density (PSAD) showed an association with csPCa detection in the exploratory multivariable model (adjusted OR 1.96 per 0.1-unit increase, 95% CI 1.04–3.71; p = 0.039). Conclusions: Cognitive MRI targeting under real-time micro-ultrasound guidance showed the same observed csPCa detection rate as software fusion within a standardized targeted-plus-systematic biopsy pathway. Wide confidence intervals preclude conclusions regarding equivalence or non-inferiority.
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BibTeX
@article{fraia2026prospective,
title = {{Prospective Comparison of Cognitive MRI-Targeted Biopsy Under Micro-Ultrasound Guidance Versus MRI/Ultrasound Fusion-Guided Transperineal Biopsy for Clinically Significant Prostate Cancer Detection}},
author = {Agostino Fraia and Sara Riolo and Francesco Di Bello and Salvatore Papi and Dario Brunello and Gianluca Nesi and Ivan Di Giulio and Giovanni Costa and Roberto Knez and Tommaso Silvestri and Bernardino de Concilio and Massimiliano Creta and Raffaele Ranavolo and Nicola Longo and Guglielmo Zeccolini and Antonio Celia},
journal = {Journal of clinical medicine},
year = {2026},
month = oct,
doi = {10.3390/jcm15197649},
url = {https://europepmc.org/article/PMC/PMC13666145},
note = {CC BY},
}
RIS
TY - JOUR
TI - Prospective Comparison of Cognitive MRI-Targeted Biopsy Under Micro-Ultrasound Guidance Versus MRI/Ultrasound Fusion-Guided Transperineal Biopsy for Clinically Significant Prostate Cancer Detection
AU - Agostino Fraia
AU - Sara Riolo
AU - Francesco Di Bello
AU - Salvatore Papi
AU - Dario Brunello
AU - Gianluca Nesi
AU - Ivan Di Giulio
AU - Giovanni Costa
AU - Roberto Knez
AU - Tommaso Silvestri
AU - Bernardino de Concilio
AU - Massimiliano Creta
AU - Raffaele Ranavolo
AU - Nicola Longo
AU - Guglielmo Zeccolini
AU - Antonio Celia
PY - 2026
DA - 2026/10/01
JO - Journal of clinical medicine
DO - 10.3390/jcm15197649
UR - https://europepmc.org/article/PMC/PMC13666145
AB - Background/Objectives: Multiparametric magnetic resonance imaging (mpMRI)-targeted biopsy has become central to prostate cancer (PCa) diagnosis. While cognitive and software-based fusion targeting have already been compared, the use of high-resolution micro-ultrasound as a real-time guidance platform for cognitive translation of MRI-defined lesions remains incompletely characterized. This study prospectively compared mpMRI-transrectal ultrasound (TRUS) fusion-guided transperineal (TP) biopsy with cognitive MRI-targeted TP biopsy under real-time ExactVu® micro-ultrasound guidance. Methods: We conducted a prospective, observational, comparative study including 58 consecutive patients with suspected PCa and at least one lesion on pre-biopsy mpMRI with a Prostate Imaging Reporting and Data System (PI-RADS) score ≥ 3. Twenty-nine patients were included in each group. The analysis used a standardized 16-core TP biopsy set comprising four targeted cores from the MRI-defined index lesion and 12 systematic cores. The primary endpoint was clinically significant PCa (csPCa) detection, defined as International Society of Urological Pathology (ISUP) Grade Group (GG) ≥ 2. Results: Overall, PCa detection was 65.5% in the fusion-guided biopsy group and 55.2% in the cognitive MRI-targeted biopsy group (absolute risk difference, 10.3 percentage points; 95% CI, −14.1 to 33.2; p = 0.592). csPCa detection was identical in the two groups (37.9% each; absolute risk difference, 0.0 percentage points; 95% CI, −23.6 to 23.6; p = 1.000). In exploratory multivariable logistic regression, biopsy technique was not associated with csPCa detection after adjustment (adjusted OR 0.73, 95% CI 0.22–2.40; p = 0.605), whereas prostate-specific antigen density (PSAD) showed an association with csPCa detection in the exploratory multivariable model (adjusted OR 1.96 per 0.1-unit increase, 95% CI 1.04–3.71; p = 0.039). Conclusions: Cognitive MRI targeting under real-time micro-ultrasound guidance showed the same observed csPCa detection rate as software fusion within a standardized targeted-plus-systematic biopsy pathway. Wide confidence intervals preclude conclusions regarding equivalence or non-inferiority.
SN - 2077-0383
ER -