Establishment of reference intervals for serum [−2]proPSA (p2PSA), %p2PSA and prostate health index in healthy men

BACKGROUND: Prostate cancer (PCa) is the second most common cancer among men worldwide. Recent research has identified [−2]proPSA (p2PSA), %p2PSA and prostate health index (phi) as new biomarkers for the early diagnosis and grading of PCa. However, few studies have used these parameters in a healthy population. In this study, we aimed to establish reference intervals (RIs) for p2PSA, %p2PSA and phi in healthy men based on age stratification. METHODS: Between April 2016 and March 2018, healthy subjects were recruited. Healthy men were then stratified into four age groups: <40 years, 40–49 years, 50–59 years and ≥60 years. Total PSA (tPSA), free PSA (fPSA), %fPSA, p2PSA, %p2PSA and phi were measured and RIs were established for p2PSA, %p2PSA and phi. RESULTS: In total, 732 healthy men were used for analysis. The RIs of phi were 9.77–48.44 for <40 years of age, 9.85–65.28 for 40–49 years of age, 9.98–39.72 for 50–59 years of age and 8.16–40.76 for ≥60 years of age. The reference values at the age of 40–49 years were generally higher than those at ≥60 years of age. CONCLUSIONS: Age-specific RIs for p2PSA, %p2PSA and phi were established in this study. This first set of established RIs will be invaluable for physicians to make precise medical decisions and carry out appropriate medical interventions.