Objectives. This study examined the multicenter clinical performance of noncomplexed (free) prostate-specific antigen (PSA) in men presenting with total PSA values between 2.5 to 20 ng/mL. Methods. Prebiopsy serum samples were obtained from 1,081 consecutively accrued, histologically diagnosed men between the ages of 40 and 75 years with total PSA values falling between 2.5 and 20 ng/mL. Total PSA was determined by either the Tosoh AIA-1200 or Hybritech method. Free PSA values were determined using the Dianon PSA II immunoradiometric method. Free PSA was expressed as a percentage of total PSA. Immunochemistry was performed at each accrual site. Results. Among men diagnosed with prostate cancer (CAP), only 4% (21/520) had proportions of free to total PSA values >25%. Conversely, among men with benign prostatic disease, only 2% (13/561) had proportions of free to total PSA values <7%. These results confirm those of previous research. Differences among sites were found in age and prostate volume. Conclusions. These data confirm that free PSA values <7% are highly suspicious for CaP whereas free PSA values >25% suggest absence of malignancy. The data also suggest that age and/or prostate volume influences the serum level of free PSA but does not affect the diagnostic cutoff points of 7% and 25%. Future analysis is needed to confirm that younger men with small prostates are at higher risk for CaP.
ASJC Scopus subject areas