Abstract
PURPOSE: This study focuses on integrating prostate-specific antigen density (PSAD) and Prostate Imaging Reporting and Data System (PI-RADS) for enhanced risk stratification in biopsy-naïve patients. METHODS: A prospective study was conducted on 339 patients with suspected prostate cancer, utilizing PSAD and PI-RADS in combination. Logistic regression models were employed, and receiver operating characteristic (ROC) analysis performed to evaluate predictive performance. The patient cohort underwent multiparametric MRI, targeted biopsy, and systematic biopsy. RESULTS: When patients were stratified into four PSAD risk groups, the rate of clinically significant prostate cancer (csPCa) increased significantly with higher PSAD levels. Logistic regression confirmed the independent contribution of PI-RADS and PSAD, highlighting their role in the prediction of csPCa. Combined models showed superior performance, as evidenced by the area under the curve (AUC) for PI-RADS category and PSAD (0.756), which exceeded that of the individual predictors (PSA AUC, 0.627, PI-RADS AUC 0.689, PSAD AUC 0.708). CONCLUSION: This study concludes that combining PSAD and PI-RADS improves diagnostic accuracy and predictive value for csPCa in biopsy-naïve men, resulting in a promising strategy to provide additional risk stratification for more accurate diagnostic decision in biopsy-naïve patients, especially in the PI-RADS 3 group.