Article Impact Level: HIGH Data Quality: STRONG Summary of JAMA. https://doi.org/10.1001/jama.2025.3579 Dr. Adam Kinnaird et al.
Points
- This randomized trial compared microultrasonography-guided biopsy with MRI fusion-guided biopsy in 678 biopsy-naive men across 20 international centers to assess their effectiveness in detecting significant prostate cancer.
- The detection rate for clinically significant prostate cancer was 47.1 percent using microultrasonography, compared to 42.6 percent with MRI/conventional ultrasound and 46.9 percent with microultrasonography/MRI fusion.
- Microultrasonography-guided biopsy was found to be non-inferior to MRI fusion-guided biopsy, with a 3.52 percent detection difference well within the 10 percent noninferiority margin set by the researchers.
- The study also confirmed that microultrasonography/MRI fusion-guided biopsy was non-inferior to MRI/conventional ultrasonography fusion-guided biopsy, suggesting reliability across multiple imaging-guided approaches.
- These results highlight microultrasonography-guided biopsy as a simpler, cost-effective alternative to MRI-based methods for prostate cancer detection, potentially improving diagnostic accessibility without compromising clinical accuracy.
Summary
This randomized clinical trial aimed to compare high-resolution microultrasonography-guided biopsy with magnetic resonance imaging (MRI) fusion-guided biopsy for detecting clinically significant prostate cancer. The study included 678 biopsy-naive men from 20 centers across eight countries, with a median age of 65 years and a prostate-specific antigen (PSA) level of 6.9 ng/mL. Participants were randomly assigned to one of three groups: microultrasonography-guided biopsy (121 participants), microultrasonography/MRI fusion-guided biopsy (226 participants), and MRI/conventional ultrasonography fusion-guided biopsy (331 participants). All groups underwent synchronous systematic biopsy. The primary outcome measured was the difference in detection rates for Gleason Grade Group 2 or higher prostate cancer.
The results showed that microultrasonography-guided biopsy was non-inferior to MRI fusion-guided biopsy for detecting clinically significant prostate cancer, with a detection rate of 47.1% in the microultrasonography group, compared to 42.6% in the MRI/conventional ultrasonography group, and 46.9% in the microultrasonography/MRI group. The noninferiority margin was set at 10%, and the difference between the microultrasonography and MRI fusion groups was 3.52% (95% CI, −3.95% to 10.92%; noninferiority P < 0.001). Additionally, microultrasonography/MRI fusion-guided biopsy was also non-inferior to MRI/conventional ultrasonography fusion-guided biopsy, with a 4.29% difference (95% CI, −4.06% to 12.63%; noninferiority P < 0.001).
These findings suggest that microultrasonography-guided biopsy is a viable alternative to MRI fusion-guided biopsy for detecting Gleason Grade Group 2 or higher prostate cancer in biopsy-naive men. Furthermore, microultrasonography offers a cost-effective, less complex option for image-guided prostate biopsy, potentially improving access to prostate cancer diagnostics while maintaining comparable accuracy.
Link to the article: https://jamanetwork.com/journals/jama/fullarticle/2831985
References Kinnaird, A., Luger, F., Cash, H., Ghai, S., Urdaneta-Salegui, L. F., Pavlovich, C. P., Brito, J., Shore, N. D., Struck, J. P., Schostak, M., Harland, N., Rodriguez-Socarrás, M., Brisbane, W. G., Lughezzani, G., Toledano, H., Ouertani, M. S., Macek, P., Fung, C., Tu, W., … Meisterhofer, K. (2025). Microultrasonography-guided vs mri-guided biopsy for prostate cancer diagnosis: The optimum randomized clinical trial. JAMA. https://doi.org/10.1001/jama.2025.3579
