Multiparametric MRI has long been considered the standard for diagnosing prostate cancer, combining T2-weighted, diffusion-weighted, and dynamic contrast–enhanced (DCE) sequences. While highly effective, this approach is resource-intensive and relies on gadolinium-based contrast, raising both logistical and financial barriers. Biparametric MRI excludes the DCE sequence and offers a faster and less costly alternative.
From April 2022 to September 2023, this trial enrolled 555 biopsy-naive men with elevated prostate-specific antigen (PSA) levels or abnormal digital rectal exams. Conducted across 22 centers in 12 countries, the study analyzed data from 490 participants after exclusions. The men, with a median age of 65 years and median PSA of 5.6 ng/mL, underwent both biparametric and multiparametric MRI. The radiologists first reported on biparametric scans without access to DCE data, then assessed the full multiparametric images.
If either imaging modality suggested clinically significant cancer, patients received targeted biopsies, with or without additional systematic sampling. The trial was designed to test whether biparametric MRI was “noninferior” to multiparametric MRI, with a 5% margin set for acceptable difference.
The study found biparametric MRI help identify cancer in 29.2% of men (143 out of 490) while multiparametric MRI detected it in 29.6% (145 out of 490). The difference was a mere −0.4 percentage points, statistically insignificant and well within the noninferiority margin.
Detection rates of clinically insignificant cancers were also nearly identical. Biparametric MRI flagged 9.2% of men, when compared with 9.6% for multiparametric scans. Also, central quality control showed that 99% of all scans were diagnostically adequate, highlighting the reliability of the abbreviated technique.
With approximately 4 million prostate MRIs performed worldwide each year, the shift to biparametric imaging could free up scanner time, shorten waiting lists, and reduce costs without compromising care. Overall, the findings suggest that, provided imaging quality is maintained, biparametric MRI has the potential to become the new global standard in prostate cancer diagnosis.
Reference:
Ng, A. B. C. D., Asif, A., Agarwal, R., Panebianco, V., Girometti, R., Ghai, S., Gómez-Gómez, E., Budäus, L., Barrett, T., Radtke, J. P., Kesch, C., De Cobelli, F., Pham, T., Taneja, S. S., Hu, J. C., Tewari, A., Rodríguez Cabello, M. Á., Dias, A. B., Mynderse, L. A., … PRIME Study Group Collaborators. (2025). Biparametric vs multiparametric MRI for prostate cancer diagnosis: The PRIME diagnostic clinical trial. JAMA: The Journal of the American Medical Association. https://doi.org/10.1001/jama.2025.13722
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