Age-related reference ranges for complexed prostate-specific antigen and complexed/total prostate-specific antigen ratio: results from East Texas Medical Center Cancer Institute screening campaign

The East Texas Medical Center Cancer Institute conducted a regional prostate cancer screening campaign over a 3-year period from 1998 through 2000. Total prostate-specific antigen (tPSA), complexed PSA (cPSA), and cPSA/tPSA ratio (c/tPSA) values were determined. To better define prostate cancer in the population, we chose to determine age-based reference ranges for these PSA isoforms in apparently healthy men. Participants (N = 12,902) between the ages of 20 and 94 were screened and demographic information and serum tPSA and cPSA values were collected across 41 centers throughout East Texas. Men with an abnormal digital rectal examination, a follow-up biopsy indicating prostatic disease, or any clinical signs and symptoms of prostatic disease were excluded. Sera from 7541 evaluable men were tested with the Bayer Immuno 1 PSA and cPSA methods at East Texas Medical Center. The resulting PSA data were then stratified by decade of age to determine age-related reference ranges for each PSA species. The cPSA values increased across all age decades: 40 to 49 years, 1.45 ng/mL; 50 to 59, 1.92 ng/mL; 60 to 69, 2.49 ng/mL; and 70 to 79, 2.77 ng/mL (95th percentile). tPSA levels also increased with age: 1.81 ng/mL, 2.45 ng/mL, 3.17 ng/mL, and 3.57, respectively. Comparatively, the c/tPSA levels remained constant (0.87), regardless of age. The upper limits of tPSA and cPSA values reported here suggest that men should be screened using lower cutoff values than are currently in use. These limits may more accurately identify prostate cancer among otherwise healthy men.