Microultrasonography-Guided vs MRI-Guided Biopsy for Prostate Cancer Diagnosis
Authors: 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, Bernard Ralla, Tahir Durmus, Anna Luisa Heinrichs, Andreas Schreyer, Hendrik Borgmann, Achot Guyoundouzian, Cohen Eddie, Gómez Sancha Fernando, Christian Samtleben, Melis Güer, Jonas Bechstein, Laura Lawaczek, Kathrin Meisterhofer
Journal: JAMA (2025)

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 &amp;amp;lt; .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 &amp;amp;lt; .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