Value of PSA density in PI-RADS 3 lesions: a single-center retrospective observational study

The aim of this study was to evaluate whether Prostate-specific antigen density (PSAD) improves risk stratification for clinically significant prostate cancer in patients with PI-RADS 3 lesions and to assess its potential role in reducing unnecessary biopsies.

A single-center retrospective observational study was conducted at Hospital Universitario Clínico San Cecilio (Granada, Spain) between January 2022 and December 2025. A total of 203 patients with a PI-RADS 3 lesion who underwent systematic and targeted biopsy were included. Clinically significant prostate cancer was defined as ISUP ≥ 2. Univariate analysis, logistic regression (age and PSAD ≥ 0.15 ng/mL/cc), ROC curve analysis, and diagnostic performance metrics for PSAD ≥ 0.15 were performed.

Prostate cancer was detected in 73/203 patients (36%) and csPCa in 21/203 (10.3%). PSAD was higher in csPCa cases (0.17 vs 0.11; p = 0.001). PSAD ≥ 0.15 was independently associated with csPCa (OR 4.56; 95% CI 1.58-13.14; p = 0.005), as was age (OR 1.08 per year; p = 0.036). PSAD yielded an AUC of 0.722 and the combined age + PSAD model an AUC of 0.751. With PSAD ≥ 0.15, sensitivity was 76.2%, specificity 61.0%, and negative predictive value 95.7%.

In conclusion, PSAD provides clinical value for risk stratification in PI-RADS 3 lesions and may support biopsy avoidance strategies in selected patients.