Abstract Background PSA assays are recommended in the screening for prostate cancer (PC) among males 50 years and older. Those with PSA results in the gray zone (between 4 ng/mL and 10 ng/mL) and a nonsuspicious digital rectal examination (DRE) may be further tested with the free PSA (fPSA) assays to improve detection of PC. PSA and fPSA are also detected in apparently healthy subjects. The goal of this study was to evaluate the distribution of high sensitivity PSA (hsPSA), fPSAII, and %fPSAII (fPSAII/hsPSA x 100) values generated on the Atellica® IM Analyzer among apparently healthy subjects by age decade. Methods Serum samples were prospectively collected from apparently healthy subjects at multiple sites across the United States: 673 males 50-70+ years presenting at primary care facilities for routine PSA testing (>120 samples in each age decade (50-59, 60-69, 70+ years) and 113 samples in each of two younger decades (30-39, 40-49 years). Distribution statistics include the mean, median, interquartile range, 2.5th, 95th, and 97.5th percentiles. Results In this study, using samples from healthy men 30-70+ years (N=786), it was observed that median hsPSA results increased with every decade from 0.682 ng/mL at 30-39 years to 2.183 ng/mL at age 70+ years. The 97.5th percentiles were below 4.0 ng/mL in men <50 years, and above 4.0 ng/mL in men >50 years. All men (100%) 30-49 years had an hsPSA result below 4.0, and 95.5% of men 50-59 years had an hsPSA result below 4.0. The percent of subjects with hsPSA values above the cut-off of 4.0 was 6.6% among men 60-69 years and 12.4% among men >70 years. Median hsPSA values for each age group were comparable to median PSA values reported for healthy men older than 50 years old without cancer undergoing routine health check-ups in the United States and other countries (median hsPSA value was 0.90 among men 50-59 years). For both hsPSA and fPSAII, it was observed that average values increased with each successive decade for subjects 30-70+ years. The range across decades was 0.904-2.183 ng/mL for hsPSA and 0.23-0.46 ng/mL for fPSAII. However, the average %fPSAII (fPSA/hsPSAx100) values did not consistently rise over time because hsPSA variances also increase, a pattern previously documented. Conclusions The distribution of Atellica® IM hsPSA and fPSAII assay values from apparently healthy males was determined. CAUTION: Investigational Device. Not available for sale. Future availability cannot be guaranteed. The results are preliminary and were achieved in unique setting with no expected timeline for completion.
Read full abstract