Background: The objective of this study was to evaluate the prostate specific antigen (PSA) density (PSAD) (the quotient of PSA and prostate volume) compared with the percent free PSA (%fPSA) in different total PSA (tPSA) ranges from 2 ng/mL to 20 ng/mL. Possible cut-off levels depending on the tPSA should be established.
Methods: In total, 1809 men with no pretreatment of the prostate were enrolled between 1996 and 2004. Total and free PSA were measured with the IMMULITE PSA and Free PSA kits (Diagnostic Products, Los Angeles, CA). Prostate volume was determined by transrectal ultrasound. The diagnostic validity of tPSA, %fPSA, and PSAD was evaluated by receiver operation characteristic (ROC) curve analysis.
Results: The PSAD differed significantly (P < 0.0001) between patients with prostate carcinoma and patients with benign prostatic hyperplasia in all analyzed ranges of tPSA and prostate volume. At the 90% and 95% sensitivity levels and regarding the area under the ROC curve (AUC) within the tPSA range of 2-4 ng/mL, The PSAD was significantly better than tPSA and %fPSA. Within the tPSA range of 4-10 ng/mL, the PSAD did not perform better than %fPSA.
Conclusions: PSAD showed a better performance than %fPSA at tPSA concentrations < 4 ng/mL for detecting prostate carcinoma, with a significantly larger AUC for PSAD (0.739) compared with %fPSA (0.667). PSAD did not perform better than %fPSA when the tPSA range of 4-10 ng/mL was analyzed. Different PSAD cut-off values of 0.05 at tPSA 2-4 ng/mL, 0.1 at tPSA 4-10 ng/mL, and 0.19 at 10-20 ng/mL were necessary to reach 95% sensitivity.