The Proportion of Prostate-specific Antigen (PSA) Complexed to α1-Antichymotrypsin Improves the Discrimination between Prostate Cancer and Benign Prostatic Hyperplasia in Men with a Total PSA of 10 to 30 μg/L

Abstract

Abstract Background: The aim of this study was to assess the diagnostic accuracy of the proportion of prostate-specific antigen (PSA) complexed to α1-antichymotrypsin (PSA-α1ACT:PSA ratio) in the differential diagnosis of prostate cancer (CaP) and benign prostatic hyperplasia (BPH) in men with total PSA of 10–30 μg/L. Methods: We used our immunoassays (ELISAs) for total PSA and PSA-α1ACT complex to study 146 men. In 123, total PSA was between 10 and 20 μg/L; 66 of these had CaP and 57 BPH. In 23 men, total PSA was between 20 and 30 μg/L; 14 of these had CaP and 9 BPH. We calculated the area under the ROC curves (AUC) for total PSA, PSA-α1ACT complex, and PSA-α1ACT:PSA ratio, and determined the cutoff points that gave sensitivities approaching 100%. Results: In the total PSA range between 10 and 20 μg/L, the AUC was significantly higher for the PSA-α1ACT:PSA ratio (0.850) than for total PSA (0.507) and PSA-α1ACT complex (0.710; P <0.0001). A cutoff ratio of 0.62 would have permitted diagnosis of all 66 patients with CaP (100% sensitivity) and avoided 19% of unnecessary biopsies (11 of 57 patients). In the total PSA range between 20 and 30 μg/L, the AUC for the PSA-α1ACT:PSA ratio (0.980; 95% confidence interval, 0.82–0.99) was greater than the AUC for total PSA (0.750; 95% confidence interval, 0.51–0.89; P = 0.042). In this range, a cutoff point of 0.64 would have permitted the correct diagnosis of all 14 patients with CaP and 6 of the 9 with BPH. Conclusions: The diagnostic accuracy of the PSA-α1ACT:PSA ratio persists at high total PSA concentrations, increasing the specificity of total PSA. Prospective studies with large numbers of patients are needed to assess whether the ratio of PSA-α1ACT to total PSA is a useful tool to avoid unnecessary prostatic biopsy in patients with a total PSA >10 μg/L.