Prospective validation of a urine-based proteomics test for predicting clinically signi cant prostate cancer in biopsy-naive patients

Prostate cancer (PCa) remains a major health burden, while existing diagnostic approaches are limited by overdiagnosis that leads to unnecessary biopsies, and by underdetection of clinically significant disease (csPCa). This study aims to prospectively validate a urine-based 19-biomarker model (19-BM) using capillary electrophoresis–mass spectrometry (CE-MS) for predicting csPCa in patients at risk. The proteomics/ peptidomics datasets from 161 biopsy-naïve patients at risk for csPCa, who underwent pre-biopsy CE-MS analysis in urine, are provided.