Effect of percent free prostate-specific antigen measurement on improving the specificity of serum prostate-specific antigen testing in Taiwanese patients

Background and pu,pose: Measurement of percent free prostate-specific antigen (fPSA) has been shown to enhance the diagnostic performance of traditional serum PSA determination. We sought to determine whether measurement of percent fPSA could improve the specificity of serum total PSA testing in the detection of prostate cancer in Taiwanese patients with intermediate serum PSA concentrations. Methods: The medical records of 211 patients examined from March 1998 through March 2000 were analyzed retrospectively; all had a serum total PSA concentration of between 4.1 and 20.0 ng/mL and negative digital rectal examination (DRE) findings, and had undergone a prostate biopsy. Biopsy results were correlated with the serum total PSA concentration and percent fPSA, which were determined using a microparticle enzyme immunoassay. Percent fPSA was calculated as the ratio of fPSA to total PSA multiplied by 100. The sensitivity and specificity were calculated and the receiver operating characteristic (ROC) curves were generated from different cutoff values of percent fPSA and total PSA. Results: Thirty-four patients (16.1%) had positive biopsy results (prostate cancer). Patients with positive biopsy results had significantly lower percent fPSA values than those with negative results (11.7% vs 16.0%, p < 0.001). Patients with a lower percent fPSA (<10%) had a higher probability of a positive biopsy result than those with a high percent fPSA (> 20%) (positive biopsy rate, 29% vs 10%, p < 0.05). Using a cutoff value of 25% fPSA or below. the sensitivity, specificity, and positive predictive value in differentiating patients with positive biopsy results from those with negative results were 97%, 13%, and 18%, respectively. Consequently, 27 unnecessary biopsies could have been avoided at the cost of missing one cancer. The area under the ROC curve was 0.68 for percent fPSA and 0.63 for total PSA (p > 0.05). Conclusions: For Taiwanese patients with a serum PSA concentration of between 4.1 and 20.0 ng/mL, the incidence of prostate cancer is relatively low; measurement of percent fPSA only weakly enhances the specificity of serum PSA testing in detecting prostate cancer.