Determination of alpha(1)-antichymotrypsin-PSA complex in serum does not improve the differentiation between benign prostatic hyperplasia and prostate cancer compared with total PSA and percent free PSA

Objectives. To evaluate the analytical performance and diagnostic utility o f alpha(1)-antichymotrypsin (ACT)prostate-specific antigen (PSA) complex in serum to improve the differentiation between benign prostatic hyperplasia (BPH) and prostate cancer (PCa). Methods. Serum concentrations of total PSA (tPSA), free PSA (fPSA), and ACT -PSA were measured in 112 untreated patients with PCa (median age 65 years) , 34 patients with BPH (median age 66 years) with histologic confirmation, and 33 men without prostate disease and with a normal digital rectal examin ation considered as controls (median age 54 years). Sera were frozen at -80 degrees C within 2 hours after collection and then analyzed during a 12-we ek period. Determinations were made with the Enzymun-Test for tPSA and fPSA and with a prototype assay for ACT-PSA on the ES system (Roche Diagnostics , Boehringer Mannheim). Results. The new ACT-PSA assay showed reliable data of analytical performan ce. The lower detection limit amounted to 0.068 mu g/L. The assay was linea r to 50 mu g/L. Spiking experiments showed a mean recovery rate of 98.2%. N o interferences of the assay were observed in patients with acute inflammat ion and highly increased ACT concentrations. The values of intra- and inter assay imprecision ranged from 1.51% to 3.48% and 2.1% to 6.3%, respectively . The median value of ACT-PSA concentrations were significantly different ( P <0.001) between controls and patients with BPH and PCa (0.40, 3.86, 5.26 mu g/L, respectively). The median fPSA/tPSA and fPSA/ACT-PSA ratios were si gnificantly different between BPH and PCa (24.3% versus 12.2%, P <0.001 and 32.9% versus 15.0%, P <0.001, respectively), but no difference of the ACT- PSA/tPSA ratio was observed (78.2% versus 78.7%, P = 0.696). Receiver opera ting characteristics of ACT-PSA (area under the curve = 0.630) and all the derivative ratios of fPSA/ACT-PSA (area = 0.737) and ACT-PSA/tPSA (area = 0 .528) were not different from that of tPSA (area = 0.619), but showed a low er discrimination power between BPH and PCa than the fPSA/tPSA ratio (area = 0.790). Conclusions. Using this prototype assay to quantify ACT-PSA in serum, we ha ve demonstrated that ACT-PSA and the calculated derivatives are not superio r in the differentiation between BPH and PCa compared with tPSA and the rat io of fPSA to tPSA. UROLOGY 53: 1160-1168, 1999. (C) 1999, Elsevier Science Inc. All rights reserved.