Non-Invasive Urine Test Predicts the Need for Biopsy in Patients on Active Surveillance for Prostate Cancer: Prospective Multisite Validation and Comparison With MRI

Document Type

Conference Proceeding

Publication Date

5-2026

Publication Title

Journal of Urology

Abstract

INTRODUCTION AND OBJECTIVES: There is a critical need to reduce the frequency of biopsies during active surveillance (AS) while maintaining timely identification of high-grade prostate cancer (PCa).We developed and externally-validated a non-invasive urine test to predict whether biopsy is necessary in patients on AS. Clinical consequences of testing were directly compared to multiparametric magnetic resonance imaging (mpMRI). METHODS: Biomarker testing models were developed using the MyProstateScore 2.0 (MPS2) 18 gene urinary panel to predict upgrading to Grade Group (GG) ≥2 and GG≥3 PCa. Per national guidelines for PCa biomarker testing, test thresholds were set to ensure >90% sensitivity for high-grade disease. Patients provided pre-AS biopsy, non-DRE urine, and the majority (84%) underwent surveillance MRI. All patients had ≥12 core systematic biopsy, andt hose with PI-RADS≥3 lesions underwent targeted sampling. The primary outcome of this analysis was upgrading to GG≥3 cancer. The diagnostic performance and clinical consequences of urinary testing to determine the need for biopsy was compared to mpMRI (using PI-RADS≥3 or PI-RADS≥4).RESULTS: The MPS2-AS models were externally validated in a prospective AS cohort from 11 academic and community practices. The validation cohort included 392 patients undergoing AS for GG1 (75%) orGG2 (25%) cancer (Table 1). On study biopsy, 50 (13%) patients upgraded to GG≥3, of which 40 (80%) were detected on systematic biopsy and 25 (50%) were detected on targeted biopsy. Use of MPS2-AS prior to biopsy would have avoided 64% of unnecessary biopsies while failing to detect 6.0% of upgrades (Table 2). By contrast, use of PI-RADS≥3 would have avoided 48% of unnecessary biopsies and failed to detect 20% of upgrades, and for PI-RADS≥4, 62% and 22%, respectively. CONCLUSIONS: In patients on AS, MPS2-AS provided actionable rule-out testing for GG≥3, demonstrating improved sensitivity and specificity versus MRI. These findings support the use of non-invasive monitoring with MPS2-AS to reduce the need for scheduled biopsies and reserve MRI for optimizing biopsy yield in higher-risk patients.

Volume

215

Issue

5S

First Page

e660

Last Page

e661

Comments

American Urological Association Annual Meeting, May 15-18, 2026, Washington, DC

DOI

10.1097/01.JU.0001191468.48904.a0.02

Link to Full Text

Share

COinS