Prospective Comparison of Cognitive MRI-Targeted Biopsy Under Micro-Ultrasound Guidance Versus MRI/Ultrasound Fusion-Guided Transperineal Biopsy for Clinically Significant Prostate Cancer Detection

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.