High-resolution microultrasonography-guided biopsy is an alternative to MRI fusion-guided biopsy for prostate cancer diagnosis.
To compare microultrasonography-guided and MRI fusion-guided biopsy.
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.
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.
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%.
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.
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.
ClinicalTrials.gov Identifier: NCT05220501.
JAMA. 2025 Mar 23 [Epub ahead of print]
Adam Kinnaird, Ferdinand Luger, Hannes Cash, Sangeet Ghai, L Felipe Urdaneta-Salegui, Christian P Pavlovich, Joseph Brito, Neal D Shore, Julian P Struck, Martin Schostak, Niklas Harland, Moisés Rodriguez-Socarrás, Wayne G Brisbane, Giovanni Lughezzani, Harry Toledano, Mohammed Salah Ouertani, Petr Macek, Christopher Fung, Wendy Tu, Andreas Gusenleitner, Karsten Günzel, Peter F Incze, Arvin K George, José G Pereira, Robert Jansen, Joseph Renzulli, Laurence Klotz, OPTIMUM Investigators
Division of Urology, Departments of Surgery and Oncology, University of Alberta, Edmonton, Canada., Department of Urology, Ordensklinikum Linz Elisabethinen, Austria., PROURO, Berlin, Germany., 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., The James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins School of Medicine, Baltimore, Maryland., Department of Urology, Yale School of Medicine, New Haven, Connecticut., Carolina Urologic Research Center, AUC Urology Specialists, Myrtle Beach, South Carolina., Department of Urology, University Hospital Brandenburg an der Havel, Brandenburg Medical School and Faculty of Health Sciences Brandenburg, Brandenburg, Germany., Department of Urology, University Clinic for Urology, Urooncology, Robot-assisted and Focal Therapy, University Clinic of Magdeburg, Germany., Department of Urology, University Hospital Tübingen, Tübingen, Germany., ICUA, Clínica CEMTRO, Madrid, Spain., Institute of Urologic Oncology, Department of Urology, UCLA Medical Center, University of California Los Angeles., Departments of Urology and Biomedical Sciences, Humanitas Clinical and Research Center, Rozzano, Italy., Department of Urology, Martigues Hospital, Martigues, France., Department of Medical Imaging, Delta Hospital, CHIREC, Belgium., Department of Urology, L'Institut Mutualiste Montsouris, Université Paris Descartes, Paris, France., 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, Oakville Trafalgar Memorial Hospital, Toronto, Canada., Division of Urology, Sunnybrook Health Sciences Center, Toronto, Canada.