Usefulness of urinary biomarker-based risk score and multiparametric MRI for clinically significant prostate cancer detection in biopsy-naïve patients

Abstract

Purpose: This study aimed to investigate the accuracy of magnetic resonance imaging (MRI), genetic urinary test (GUT) and prostate cancer prevention trial risk calculator version 2.0 (PCPTRC2) for the clinically significant prostate cancer (csPCa) diagnostic in biopsynaïve patients. *Methods and Materials: In a single center study between 2021 and 2024 participants underwent prostate mpMRI, GUT and ultrasound (US) guided biopsy. The csPCa risk was calculated using PCPTRC2. Post digital rectal examination (DRE) GUT was performed measuring RNA levels of PCA3 and T:E fusion genes. The McNemar test compared detection rates between modalities. Results: 208 (mean age 62.9 years +/- 8.2) men were included prospectively. A positive GUT score was found in 67.8% and PIRADS ≥3 in 81.7% of all cases. The combination of GUT with mpMRI showed significantly higher sensitivity (99.1%) than GUT and mpMRI alone, 84.4% and 93.8%, respectively (p ≤ 0.05). Similarly, very high sensitivity (99.0%) was achieved by combining mpMRI with PCPTCR2. Nevertheless, mpMRI plus GUT combination exceeded mpMRI plus PCPTCR2 by allowing to save a higher fraction of unnecessary biopsies, 25% and 2,4%, respectively. Conclusions: GUT and mpMRI combination would allow saving a substantial fraction of unnecessary biopsies with minimal risk of missing csPCa cases. Clinical Relevance/Application: The combination of genetic urinary testing (GUT) and MRI enhanced the detection sensitivity of csPCa while substantially reducing unnecessary biopsies, thereby improving diagnostic efficiency and patient outcomes.