Objective: To evaluate the analytical performance and diagnostic utility of prostate specific antigen (PSA) bound to alpha 1-antichymotrypsin (ACT) in serum to improve the differentiation between benign prostatic hyperplasia (BPH) and prostate cancer (PCa).
Methods: A total of 351 white men 21 to 88 years old were analysed. Serum concentration of tPSA, free PSA (fPSA) and ACT-PSA were measured in 163 untreated PCa patients (median age 66 years), 94 patients with histologically or clinically confirmed BPH (median age 65 years) and 94 men without prostate disease considered as controls (median age 54 years). The Elecsys system 2010 (Roche Diagnostics, Germany) was used for the determinations of tPSA and fPSA. The ACT-PSA assay is a new developed prototype on the ES system (Roche Diagnostics, Germany).
Results: The ACT-PSA assay showed reliable data of analytical performance in comparison to established assays for tPSA and fPSA. The median concentrations of tPSA (PCa: 9.22 micrograms/L, BPH: 2.28 micrograms/L, controls: 0.99 microgram/L) and ACT-PSA (7.99 micrograms/L vs. 1.63 micrograms/L vs. 0.58 microgram/L) were significantly different, respectively. The median ratios of fPSA/tPSA (PCa: 12.3%, BPH: 25.4%), ACT-PSA/tPSA (90.5% vs. 66.6%) and fPSA/ACT-PSA (14.0% vs. 38.6%) were significantly different between PCa and BPH patients. Significant differences of ratios between BPH and controls were not observed. Receiver operating characteristics analysis (tPSA up to 20 micrograms/L) for discrimination between PCa and BPH showed that the ratios fPSA/tPSA (area under the curve: 0.861) and fPSA/ACT-PSA (0.847) were significantly different from tPSA (0.663), but ACT-PSA (0.733) alone and also the ratio of ACT-PSA/tPSA (0.780) were not significantly different from tPSA (0.663).
Conclusion: The ratio fPSA/tPSA showed the best discrimination between BPH and PCa. The single or additional determination of ACT-PSA to tPSA does not improve the differentiation between the two groups of patients.