{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T10:57:08Z","timestamp":1790938628623,"version":"4.1.0"},"reference-count":22,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T00:00:00Z","timestamp":1790899200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J. Clin. Med.","JCM"],"abstract":"<jats:p>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\u00ae 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 \u2265 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) \u2265 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, \u221214.1 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, \u221223.6 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\u20132.40; 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\u20133.71; 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.<\/jats:p>","DOI":"10.3390\/jcm15197649","type":"journal-article","created":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T10:14:56Z","timestamp":1790936096000},"page":"7649","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"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"],"prefix":"10.3390","volume":"15","author":[{"given":"Agostino","family":"Fraia","sequence":"first","affiliation":[{"name":"Department of Urology, San Giuseppe Moscati Hospital, 81031 Aversa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-1139-6825","authenticated-orcid":false,"given":"Sara","family":"Riolo","sequence":"additional","affiliation":[{"name":"Department of Urology, La Sapienza University, 00185 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"conceptualization","vocabulary":"credit"},{"role":"writing-original-draft","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8585-3701","authenticated-orcid":false,"given":"Francesco","family":"Di Bello","sequence":"additional","affiliation":[{"name":"Department of Urology, Fundaci\u00f3 Puigvert, 08025 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"formal-analysis","vocabulary":"credit"}]},{"given":"Salvatore","family":"Papi","sequence":"additional","affiliation":[{"name":"Department of Urology, San Giuseppe Moscati Hospital, 81031 Aversa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"data-curation","vocabulary":"credit"}]},{"given":"Dario","family":"Brunello","sequence":"additional","affiliation":[{"name":"Urology Unit, Department of Surgery, Dentistry, Pediatrics and Gynecology, Azienda Ospedaliera Universitaria Integrata, University of Verona, 37126 Verona, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"data-curation","vocabulary":"credit"}]},{"given":"Gianluca","family":"Nesi","sequence":"additional","affiliation":[{"name":"Department of Urology, La Sapienza University, 00185 Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"data-curation","vocabulary":"credit"}]},{"given":"Ivan Di","family":"Giulio","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"investigation","vocabulary":"credit"}]},{"given":"Giovanni","family":"Costa","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"methodology","vocabulary":"credit"}]},{"given":"Roberto","family":"Knez","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"resources","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8195-7784","authenticated-orcid":false,"given":"Tommaso","family":"Silvestri","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Bernardino","family":"de Concilio","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2082-3330","authenticated-orcid":false,"given":"Massimiliano","family":"Creta","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples \u201cFederico II\u201d, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"writing-review-editing","vocabulary":"credit"}]},{"given":"Raffaele","family":"Ranavolo","sequence":"additional","affiliation":[{"name":"Department of Urology, San Giuseppe Moscati Hospital, 81031 Aversa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"validation","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-3394-0596","authenticated-orcid":false,"given":"Nicola","family":"Longo","sequence":"additional","affiliation":[{"name":"Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples \u201cFederico II\u201d, 80131 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"validation","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"}]},{"given":"Guglielmo","family":"Zeccolini","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"project-administration","vocabulary":"credit"}]},{"given":"Antonio","family":"Celia","sequence":"additional","affiliation":[{"name":"Department of Urology, San Bassiano Hospital, 36061 Bassano del Grappa, Italy"}],"role":[{"vocabulary":"crossref","role":"author"},{"role":"validation","vocabulary":"credit"},{"role":"supervision","vocabulary":"credit"},{"role":"project-administration","vocabulary":"credit"}]}],"member":"1968","published-online":{"date-parts":[[2026,10,2]]},"reference":[{"key":"ref_1","unstructured":"European Association of Urology (2026). 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