External Validation of the PRI-MUS Scoring System: A Secondary Analysis of the OPTIMUM Randomized Controlled Trial.

Abstract

Micro-ultrasonography (microUS)-guided biopsy has emerged as an alternative to MRI fusion-guided biopsy for the diagnosis of prostate cancer. This study aimed to externally validate the PRI-MUS (Prostate Risk Identification using Micro-Ultrasound) scoring system for predicting clinically significant prostate cancer (csPCa) using data from the OPTIMUM trial. A secondary analysis of the OPTIMUM trial was conducted to evaluate the diagnostic performance of the PRI-MUS scoring system. The analysis included patients who underwent microUS-guided prostate biopsy, with each core assigned a PRI-MUS score. The diagnostic performance of the PRI-MUS scoring system for identifying csPCa was assessed at per-core and per-lesion levels. 347 patients receiving microUS-guided biopsy were included. At the per-core level, 4,590 biopsy cores were analyzed and assigned a PRI-MUS score. When comparing PRI-MUS 1-2 versus 3-5, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for detecting csPCa were 72%, 74%, 37%, and 93%, respectively. The AUC was 0.78 (95% [CI]: 0.76-0.8). At the per-lesion level, 322 lesions were analyzed. When comparing PRI-MUS 1-2 versus 3-5, the corresponding sensitivity, specificity, PPV, and NPV were 92%, 34%, 55%, and 83%, respectively. The AUC was 0.78 (95% CI: 0.73-0.82). Nineteen high-risk anterior lesions were biopsied, with csPCa detected in 11 (57.8%). The PRI-MUS scoring system demonstrated high sensitivity and NPV for diagnosing csPCa at both the per-core and per-lesion levels, supporting its validity as a risk-stratification tool for microUS-guided biopsy.