Br J Cancer. 2026; doi:10.1038/s41416-026-03602-y

Prostate cancer (PCa) continues to represent a significant public health burden. Existing diagnostic methods are limited, among other things, by overdiagnosis, which can lead to unnecessary biopsies, and by the failure to detect clinically significant prostate cancer (csPCa).

A recent prospective study confirms the diagnostic performance of the established CE-MS-based urine test for the detection of clinically significant prostate cancer. The study included 161 biopsy-naïve men with suspected prostate cancer. The test, based on 19 urinary biomarkers (19-BM, commercially available as protexam PSM), was compared with PSA, clinical risk models and multiparametric MRI (mpMRI).

In a direct comparison, the urine test showed high sensitivity (94%), and performed better than the individual established methods. It achieved an AUC of 0.79. The urine test thus demonstrated higher diagnostic accuracy in this study cohort than PSA (AUC 0.54), the ERSPC risk model (AUC 0.63), PSA density (AUC 0.61) and mpMRI (AUC 0.65), when each method was considered individually.

The results were particularly informative in men whose MRI scans did not show any clearly suspicious lesions. In this group, the urine test detected 75% of clinically significant tumours while achieving a specificity of 90%. It therefore provided additional information on relevant tumours that might have remained undetected if imaging alone had been used for assessment.

The urine-based proteomic test can therefore provide a valuable addition to current diagnostic methods and, also in combination with mpMRI, could potentially help reduce the number of unnecessary invasive procedures.

Another key component is protexam PCU. From the same urine CE-MS profile, protexam PCU informs about the presence of prostate cancer, while subsequent assessment with protexam PSM further stratifies clinically significant disease, improving the specificity of downstream biopsy selection. The complementarity analysis supports this sequential concept, with concordant positivity substantially enriching the population with true disease presence. Among patients with both classifiers positive, 97% had PCa, leaving only 3% without cancer, without PCa, while 82% had clinically significant PCa.