The purpose of this study was to analyze the role of total prostate-specific-antigen (PSA) and free-PSA levels in the diagnosis and clinical staging of prostate cancer. We determined total-PSA serum concentration and free-PSA percentage in 352 patients, 234 with benign prostatic hyperplasia (BPH) and 118 with prostate cancer. Clinical stage of patients with prostate cancer was T1 N0 M0 in 17, T2 N0 M0 in 27, T3-4 N0 M0 in 34 and T1-4 N0-3 M0-1 in 40. Median total-PSA serum concentration was 3.1 ng/ml in patients with BPH and 26.9 ng/ml in patients with prostate cancer, p F 0.0001. Median free-PSA level was 16.7% in patients with BPH and 8.1% in patients with prostate cancer, p F 0.0001. A cutpoint of 4.0 ng/ml detected 96.6% of the prostate cancer, but the percent rate of negative biopsies was 42.1%. For a free-PSA level of 25% in patients with total PSA greater than 4.0 ng/ml, the sensitivity was 97.4%, and the decrease in negative biopsies was 21%. Median total-PSA serum concentration in patients with prostate cancer according to clinical stage was 8.9 ng/ml for T1 N0 M0, 12.9 ng/ml for T2 N0 M0, 29.9 ng/ml for T3-4 N0 M0 and 317 ng/ml for T1-4 N1-3 M0-1, p F 0.001. Prostate-specific antigen (PSA) has become the most clinically useful tumor marker available for the diagnosis and management of prostate cancer. However, the PSA test lacks sufficient specificity for to be considered an ideal tumor marker for the detection of early prostate cancer, since it is not specific for prostate cancer. In fact, about 23% of patients with benign prostatic hyperplasia (BPH) without clinical evidence of prostate cancer present PSA ranges of 4 to 10 ng/ml and 5% more than 10 ng/ml (Oesterling, 1991). In the early diagnosis by normal digital rectal examination of prostate cancer in men with serum PSA level between 4.1 and 10 ng/ml, specificity of the PSA test is poor due to the high false-positive rate showed by 80% of negative biopsies (Catalona et al., 1994).Recent investigations have shown that there are several molecular forms of PSA in the serum, and the concentration varies according to the disease of the prostate. PSA in the serum of patients with prostate cancer occurs predominantly in complex with a1-antichymotrypsin (Lilja et al., 1991;Christensson et al., 1993). The percentage of free PSA has been introduced as a measure of improving the specificity of the test for total PSA in the early detection of prostate cancer (Filella et al., 1995;Catalona et al., 1995). This new parameter appears to be also more costeffective than PSA density, since it eliminates ultrasonography to calculate the prostatic volume .The optimal cutpoint of the percentage of free PSA has not been established for the diagnosis of prostate cancer, nor has its clinical utility in the clinical staging and monitoring of this neoplasm. The aim of the present study was to analyze the role of total-PSA and free-PSA levels in the diagnosis and clinical staging of prostate cancer.
MATERIAL AND METHODSTotal and free PSA serum concentrations were measured, a...