{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T02:33:46Z","timestamp":1793241226189,"version":"4.5.0"},"reference-count":32,"publisher":"American Medical Association (AMA)","issue":"19","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,5,20]]},"abstract":"\n Importance<\/jats:title>\n High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To compare microultrasonography-guided and MRI fusion-guided biopsy.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n A multicenter, international, open-label, randomized, noninferiority trial of biopsy-naive men from 20 centers (8 countries) with clinical suspicion of prostate cancer (elevated prostate-specific antigen [PSA] and\/or abnormal digital rectal examination findings) from December 2021 to September 2024.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Participants were assigned to receive either microultrasonography-guided biopsy (n\u2009=\u2009121), microultrasonography\/MRI fusion-guided biopsy (microultrasonography\/MRI; n\u2009=\u2009226, in which microultrasonography biopsies were performed prior to unblinding the MRI), or MRI\/conventional US fusion-guided biopsy (MRI\/conventional ultrasonography; n\u2009=\u2009331). All participants received synchronous systematic biopsy.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers using microultrasonography plus systematic biopsy vs MRI\/conventional ultrasonography plus systematic biopsy. The secondary outcome was the difference in detection of Gleason Grade Group 2 or higher cancers found using microultrasonography\/MRI plus systematic biopsy vs MRI\/conventional ultrasonography plus systematic biopsy. The noninferiority margin was set at 10%.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n A total of 802 men underwent randomization and 678 underwent biopsy. Median (IQR) age was 65 (59-70) years and prostate-specific antigen level was 6.9 (5.2-9.8) ng\/mL; 83% self-identified as White. Gleason Grade Group 2 or higher cancer was detected in 57 participants (47.1%) in the microultrasonography group, in 141 (42.6%) in the MRI\/conventional ultrasonography group, and in 106 (46.9%) in the microultrasonography\/MRI group. Microultrasonography-guided biopsy was noninferior to MRI fusion-guided biopsy (difference, 3.52% [95% CI, \u22123.95% to 10.92%]; noninferiority\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Combined biopsy with microultrasonography\/MRI was also noninferior to MRI\/conventional ultrasonography software-assisted MRI fusion biopsy using conventional ultrasonography devices (difference, 4.29% [95% CI, \u22124.06% to 12.63%]; noninferiority\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). The rate of Gleason Grade Group 2 or higher cancer diagnosed by targeted biopsy only was 38.0% in the microultrasonography group, 34.1% in the MRI\/conventional ultrasonography group, and 40.3% in the microultrasonography\/MRI group; these differences were not significant.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n The use of microultrasonography-guided biopsy was noninferior to MRI\/conventional ultrasonography fusion-guided biopsy for the detection of Gleason Grade Group 2 or higher prostate cancer in biopsy-naive men. Microultrasonography may provide an alternative to MRI for image-guided prostate biopsy.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05220501<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.3579","type":"journal-article","created":{"date-parts":[[2025,3,23]],"date-time":"2025-03-23T06:30:25Z","timestamp":1742711425000},"page":"1679","source":"Crossref","is-referenced-by-count":91,"title":["Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis"],"prefix":"10.1001","volume":"333","author":[{"given":"Adam","family":"Kinnaird","sequence":"first","affiliation":[{"name":"Division of Urology, Departments of Surgery and Oncology, University of Alberta, Edmonton, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ferdinand","family":"Luger","sequence":"additional","affiliation":[{"name":"Department of Urology, Ordensklinikum Linz Elisabethinen, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannes","family":"Cash","sequence":"additional","affiliation":[{"name":"PROURO, Berlin, Germany"},{"name":"Department of Urology, University Clinic for Urology, Urooncology, Robot-assisted and Focal Therapy, University Clinic of Magdeburg, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sangeet","family":"Ghai","sequence":"additional","affiliation":[{"name":"University Medical Imaging Toronto, Joint Department of Medical Imaging, University Health Network\u2013Mount Sinai Hospital\u2013Women\u2019s College Hospital, University of Toronto, Toronto General Hospital, Toronto, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. 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