A RECENT study aimed to determine whether high-resolution microultrasonography-guided biopsy is noninferior to MRI fusion-guided biopsy in detecting clinically significant prostate cancer. The trial, which included 678 participants, found that microultrasonography-guided biopsy was indeed noninferior to MRI fusion-guided biopsy for detecting Gleason Grade Group 2 or higher prostate cancer. Specifically, the difference in detection rates was 3.52%, with a 95% confidence interval of −3.95% to 10.92%, and a noninferiority P value of less than 0.001.
The study was conducted as a multicenter, international, open-label, randomised noninferiority trial across 20 centres in eight countries. Participants were biopsy-naive men with clinical suspicion of prostate cancer, based on elevated prostate-specific antigen (PSA) levels or abnormal digital rectal examination findings. They were randomised to receive one of three biopsy methods: microultrasonography-guided biopsy, microultrasonography/MRI fusion-guided biopsy, or MRI/conventional ultrasonography fusion-guided biopsy. All participants also underwent synchronous systematic biopsy.
The primary outcome was to assess the difference in the detection of Gleason Grade Group 2 or higher cancers between microultrasonography and MRI/conventional ultrasonography fusion-guided biopsies. Secondary outcomes compared microultrasonography/MRI fusion with MRI/conventional ultrasonography fusion. The noninferiority margin was set at 10%, and the results showed that microultrasonography-guided biopsy met this margin, proving to be comparable to MRI fusion-guided biopsy in terms of cancer detection.
Additionally, the study demonstrated that the use of microultrasonography-guided biopsy could provide an alternative to MRI for image-guided prostate biopsy. While the targeted biopsy alone detected similar rates of Gleason Grade Group 2 or higher cancers across all groups, the findings suggest that microultrasonography could be a viable option for prostate cancer diagnosis, potentially offering more accessible and cost-effective imaging for patients.
Reference
Kinnaird A, Luger F, Cash H, et al. Microultrasonography-Guided vs MRI-guided biopsy for prostate cancer diagnosis: the OPTIMUM randomized clinical trial. JAMA. 2025;DOI:10.1001/jama.2025.3579
