Diagnostic evaluation and incorporation of PSA density and the prostate imaging and data reporting system (PIRADS)...

The diagnostic approach for prostate cancer still depends on PSA and DRE.

to evaluate the diagnostic validity of PSA-Density and PIRADSv2 as diagnostic tests regarding biopsy results, and to design nomograms that include all diagnostic variables for malignancy, significant tumor (ST) and high-grade tumor.

Cross-sectional study which included men with PSA ≥ 4 ng/ml and/or suspicious DRE, PIRADSv2 ≥ 3 lesions on multiparametric MRI and prostate biopsy. The gold standard test was the maximum ISUP of the targeted biopsy per patient (malignancy: ISUP ≥ 1, ST: ISUP ≥ 2, high-grade tumor: ISUP ≥ 4). Association and logistic regression tests were used and diagnostic validity parameters using PSA-Density and PIRADSv2 classification was analyzed. Nomograms were designed for malignancy, ST, and high-grade tumor using the best model selection procedure from all possible equations.

336 men with median age, PSA and PSA-Density of 67.7 years (IQR:12.6), 6.3 ng/ml (IQR:3.3) and 0.12 ng/ml/cc (IQR:0.10), respectively; 63 index lesions were PIRADS3, 204 PIRADS4, and 69 PIRADS5. 65.8% and 37.8% were malignant and ST, respectively. The significant positive association highlighted between malignancy and ST with age, DRE, PSA-Density and PIRADSv2. PSA-Density and PIRADSv2 ≥ 3 presented the highest sensitivity to detect malignancy, and their combination showed sensitivity nearly 95% (AUC:0.803). Nomograms for malignancy and ST included the variables age, DRE, PSA-Density, and PIRADSv2 with a sensitivity closely 91% (AUC:0.833), and a specificity of almost 85% for ST, exposing risk < 5% for ST when PSA-Density is < 0.15, not suspicious DRE and PIRADS3.

PSA-Density and PIRADSv2 classification in risk nomograms can provide highly relevant information to increase the accuracy in the diagnosis of PC and ST.