IMPORTANCE: High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis. OBJECTIVE: To compare microultrasonography-guided and MRI fusion-guided biopsy. DESIGN, SETTING, AND PARTICIPANTS: 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. INTERVENTIONS: Participants were assigned to receive either microultrasonography-guided biopsy (n = 121), microultrasonography/MRI fusion-guided biopsy (microultrasonography/MRI; n = 226, in which microultrasonography biopsies were performed prior to unblinding the MRI), or MRI/conventional US fusion-guided biopsy (MRI/conventional ultrasonography; n = 331). All participants received synchronous systematic biopsy. MAIN OUTCOMES AND MEASURES: 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%. RESULTS: 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, -3.95% to 10.92%]; noninferiority P < .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, -4.06% to 12.63%]; noninferiority P < .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. CONCLUSIONS AND RELEVANCE: 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05220501.

Carolina Urologic Research Center AUC Urology Specialists Myrtle Beach South Carolina

Department of Biomedical Sciences Humanitas University Pieve Emanuele Italy

Department of Medical Imaging Delta Hospital CHIREC Belgium

Department of Radiology and Diagnostic Imaging University of Alberta Edmonton Canada

Department of Urology Faculty of Health Sciences Brandenburg Brandenburg Medical School Theodor Fontane Neuruppin Germany

Department of Urology General University Hospital Prague Czech Republic

Department of Urology L'Institut Mutualiste Montsouris Université Paris Descartes Paris France

Department of Urology Martigues Hospital Martigues France

Department of Urology Oakville Trafalgar Memorial Hospital Toronto Canada

Department of Urology Ordensklinikum Linz Elisabethinen Austria

Department of Urology University Clinic for Urology Urooncology Robot assisted and Focal Therapy University Clinic of Magdeburg Germany

Department of Urology University Hospital Brandenburg an der Havel Brandenburg Medical School and Faculty of Health Sciences Brandenburg Brandenburg Germany

Department of Urology University Hospital Tübingen Tübingen Germany

Department of Urology University of Florida Gainesville

Department of Urology Yale School of Medicine New Haven Connecticut

Departments of Urology and Biomedical Sciences Humanitas Clinical and Research Center Rozzano Italy

Division of Urology Departments of Surgery and Oncology University of Alberta Edmonton Canada

Division of Urology Sunnybrook Health Sciences Center Toronto Canada

ICUA Clínica CEMTRO Madrid Spain

Institute of Urologic Oncology Department of Urology UCLA Medical Center University of California Los Angeles

LOGICURO Berlin Germany

PROURO Berlin Germany

The James Buchanan Brady Urological Institute and Department of Urology Johns Hopkins School of Medicine Baltimore Maryland

University Medical Imaging Toronto Joint Department of Medical Imaging University Health Network Mount Sinai Hospital Women's College Hospital University of Toronto Toronto General Hospital Toronto Canada

Urología Clínica Bilbao Clínica IMQ Zorrotzaurre Bilbao Spain

doi: 10.1001/jama.2024.3841 PubMed

doi: 10.1001/jama.2025.0228 PubMed

doi: 10.1001/jama.2018.3710 PubMed

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Kasivisvanathan V, Rannikko AS, Borghi M, et al. ; PRECISION Study Group Collaborators . MRI-targeted or standard biopsy for prostate-cancer diagnosis. N Engl J Med. 2018;378(19):1767-1777. doi:10.1056/NEJMoa1801993 PubMed DOI PMC

Ahmed HU, El-Shater Bosaily A, Brown LC, et al. ; PROMIS study group . Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017;389(10071):815-822. doi:10.1016/S0140-6736(16)32401-1 PubMed DOI

Lovegrove CE, Miah S, El-Shater Bosaily A, et al. . Comparison of transrectal ultrasound biopsy to transperineal template mapping biopsies stratified by multiparametric magnetic resonance imaging score in the PROMIS trial. J Urol. 2020;203(1):100-107. doi:10.1097/JU.0000000000000455 PubMed DOI

Kinnaird A, Sharma V, Chuang R, et al. . Risk of prostate cancer after a negative magnetic resonance imaging guided biopsy. J Urol. 2020;204(6):1180-1186. doi:10.1097/JU.0000000000001232 PubMed DOI

Soerensen SJC, Li S, Langston ME, Fan RE, Rusu M, Sonn GA. Trends in pre-biopsy MRI usage for prostate cancer detection, 2007-2022. Prostate Cancer Prostatic Dis. Published online September 21, 2024. doi:10.1038/s41391-024-00896-y PubMed DOI PMC

Laurence Klotz CM. Can high resolution micro-ultrasound replace MRI in the diagnosis of prostate cancer? Eur Urol Focus. 2020;6(2):419-423. doi:10.1016/j.euf.2019.11.006 PubMed DOI

Ghai S, Eure G, Fradet V, et al. . Assessing cancer risk on novel 29 mhz micro-ultrasound images of the prostate: creation of the micro-ultrasound protocol for prostate risk identification. J Urol. 2016;196(2):562-569. doi:10.1016/j.juro.2015.12.093 PubMed DOI

Sountoulides P, Pyrgidis N, Polyzos SA, et al. . Micro-ultrasound–guided vs multiparametric magnetic resonance imaging-targeted biopsy in the detection of prostate cancer: a systematic review and meta-analysis. J Urol. 2021;205(5):1254-1262. doi:10.1097/JU.0000000000001639 PubMed DOI

Albers P, Wang B, Broomfield S, Medina Martín A, Fung C, Kinnaird A. Micro-ultrasound versus magnetic resonance imaging in prostate cancer active surveillance. Eur Urol Open Sci. 2022;46:33-35. doi:10.1016/j.euros.2022.09.019 PubMed DOI PMC

Lughezzani G, Maffei D, Saita A, et al. . Diagnostic accuracy of microultrasound in patients with a suspicion of prostate cancer at magnetic resonance imaging: a single-institutional prospective study. Eur Urol Focus. 2021;7(5):1019-1026. doi:10.1016/j.euf.2020.09.013 PubMed DOI

Ghai S, Perlis N, Atallah C, et al. . Comparison of micro-US and multiparametric MRI for prostate cancer detection in biopsy-naive men. Radiology. 2022;305(2):390-398. doi:10.1148/radiol.212163 PubMed DOI

Wang B, Broomfield S, Martín AM, Albers P, Fung C, Kinnaird A. Detection of clinically significant prostate cancer by micro-ultrasound-informed systematic biopsy during MRI/micro-ultrasound fusion biopsy. Can Urol Assoc J. 2023;17(4):117-120. PubMed PMC

Claros OR, Tourinho-Barbosa RR, Fregeville A, et al. . Comparison of initial experience with transrectal magnetic resonance imaging cognitive guided micro-ultrasound biopsies versus established transperineal robotic ultrasound magnetic resonance imaging fusion biopsies for prostate cancer. J Urol. 2020;203(5):918-925. doi:10.1097/JU.0000000000000692 PubMed DOI

Maffei D, Fasulo V, Avolio PP, et al. . Diagnostic performance of microUltrasound at MRI-guided confirmatory biopsy in patients under active surveillance for low-risk prostate cancer. Prostate. 2023;83(9):886-895. doi:10.1002/pros.24532 PubMed DOI

Pensa J, Brisbane W, Kinnaird A, et al. . Evaluation of prostate cancer detection using micro-ultrasound versus MRI through co-registration to whole-mount pathology. Sci Rep. 2024;14(1):18910. doi:10.1038/s41598-024-69804-7 PubMed DOI PMC

Hofbauer SL, Luger F, Harland N, et al. . A non-inferiority comparative analysis of micro-ultrasonography and MRI-targeted biopsy in men at risk of prostate cancer. BJU Int. 2022;129(5):648-654. doi:10.1111/bju.15635 PubMed DOI

Klotz L, Lughezzani G, Maffei D, et al. . Comparison of micro-ultrasound and multiparametric magnetic resonance imaging for prostate cancer: a multicenter, prospective analysis. Can Urol Assoc J. 2021;15(1):E11-E16. PubMed PMC

You C, Li X, Du Y, et al. . The microultrasound-guided prostate biopsy in detection of prostate cancer: a systematic review and meta-analysis. J Endourol. 2022;36(3):394-402. doi:10.1089/end.2021.0361 PubMed DOI

García Rojo E, García Gómez B, Sopeña Sutil R, et al. . Comparison in detection rate of clinically significant prostate cancer between microultrasound-guided prostate biopsy (ExactVu) and multiparametric resonance imaging-guided prostate biopsy (Koelis System). Urology. 2024;183:163-169. doi:10.1016/j.urology.2023.09.049 PubMed DOI

Klotz L, Andriole G, Cash H, et al. . Optimization of prostate biopsy - Micro-Ultrasound versus MRI (OPTIMUM): a 3-arm randomized controlled trial evaluating the role of 29 MHz micro-ultrasound in guiding prostate biopsy in men with clinical suspicion of prostate cancer. Contemp Clin Trials. 2022;112:106618. doi:10.1016/j.cct.2021.106618 PubMed DOI

Rosario DJ, Lane JA, Metcalfe C, et al. . Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. BMJ. 2012;344:d7894. doi:10.1136/bmj.d7894 PubMed DOI PMC

Elkhoury FF, Felker ER, Kwan L, et al. . Comparison of targeted vs systematic prostate biopsy in men who are biopsy naive: the Prospective Assessment of Image Registration in the Diagnosis of Prostate Cancer (PAIREDCAP) study. JAMA Surg. 2019;154(9):811-818. doi:10.1001/jamasurg.2019.1734 PubMed DOI PMC

Klotz L, Chin J, Black PC, et al. . Comparison of multiparametric magnetic resonance imaging–targeted biopsy with systematic transrectal ultrasonography biopsy for biopsy-naive men at risk for prostate cancer: a phase 3 randomized clinical trial. JAMA Oncol. 2021;7(4):534-542. doi:10.1001/jamaoncol.2020.7589 PubMed DOI PMC

Turkbey B, Rosenkrantz AB, Haider MA, et al. . Prostate Imaging Reporting and Data System Version 2.1: 2019 update of prostate imaging reporting and data system version 2. Eur Urol. 2019;76(3):340-351. doi:10.1016/j.eururo.2019.02.033 PubMed DOI

James ND, Tannock I, N’Dow J, et al. . The Lancet Commission on prostate cancer: planning for the surge in cases. Lancet. 2024;403(10437):1683-1722. doi:10.1016/S0140-6736(24)00651-2 PubMed DOI PMC

Cash H, Hofbauer SL, Shore N, et al. . Prostate cancer detection by novice micro-ultrasound users enrolled in a training program. Société Int d’Urologie J. 2022;3(2):62-68. doi:10.48083/KKVJ7280 DOI

Meng X, Rosenkrantz AB, Huang R, et al. . The institutional learning curve of magnetic resonance imaging-ultrasound fusion targeted prostate biopsy: temporal improvements in cancer detection in 4 years. J Urol. 2018;200(5):1022-1029. doi:10.1016/j.juro.2018.06.012 PubMed DOI

Hugosson J, Månsson M, Wallström J, et al. ; GÖTEBORG-2 Trial Investigators . Prostate cancer screening with PSA and MRI followed by targeted biopsy only. N Engl J Med. 2022;387(23):2126-2137. doi:10.1056/NEJMoa2209454 PubMed DOI PMC

Hugosson J, Godtman RA, Wallstrom J, et al. . Results after four years of screening for prostate cancer with PSA and MRI. N Engl J Med. 2024;391(12):1083-1095. doi:10.1056/NEJMoa2406050 PubMed DOI

Lu AJ, Syed JS, Ghabili K, et al. . Role of core number and location in targeted magnetic resonance imaging-ultrasound fusion prostate biopsy. Eur Urol. 2019;76(1):14-17. doi:10.1016/j.eururo.2019.04.008 PubMed DOI

Norris JM, Kinnaird A, Margolis DJ, Padhani AR, Walz J, Kasivisvanathan V. Developments in MRI-targeted prostate biopsy. Curr Opin Urol. 2020;30(1):1-8. doi:10.1097/MOU.0000000000000683 PubMed DOI

Albers P, Bennett J, Evans M, et al. . Value of incremental biopsy cores for microultrasound targeted prostate biopsies. Urology. 2024;184:142-148. doi:10.1016/j.urology.2023.11.018 PubMed DOI

Zobrazit více v PubMed

ClinicalTrials.gov
NCT05220501