Age-specific reference range of prostate-specific antigen and prostate cancer detection in population-based screening cohort in Japan: verification of Japanese Urological Association Guideline for prostate cancer.

OBJECTIVES: To investigate the age-specific reference range of prostate-specific antigen and clinical characteristics of screening-detected cancer in prostate-specific antigen-based screening, and to verify the age-specific prostate-specific antigen cut-offs in the Japanese Urological Association Guidelines. METHODS: Prostate-specific antigen distributions were estimated in a total of 69,028 screening tests according to the age of the participants in population screening from 2000 to 2013. The age-specific reference range of prostate-specific antigen for detection of cancer was investigated by analyzing the receiver operating characteristic curves. Furthermore, the clinicopathological features of screening-detected cancer with serum prostate-specific antigen levels below the age-specific prostate-specific antigen cut-off in the Japanese Urological Association Guidelines were also investigated. RESULTS: Of all 69,028 screens, 2053 prostate biopsies (2.97%) were carried out and 549 cases of cancer (0.79%) were diagnosed. The 95th percentiles in all participants aged 54-59, 60-64, 65-69 and 70-75 years old were 2.90, 3.60, 4.10, and 4.70 ng/mL, respectively. The optimal prostate-specific antigen cut-offs for cancer detection determined from the receiver operating characteristic curves were 2.3 and 2.6 for the age ranges 54-69 and 70-75 years, respectively. These values were lower than the age-specific cut-offs in the Japanese Urological Association Guidelines. Of all 137 patients with prostate-specific antigen levels below the age-specific cut-offs in the Japanese Urological Association Guidelines, 80 (58.4%) had unfavorable clinicopathological features as active surveillance criteria. CONCLUSIONS: The age-specific reference range of prostate-specific antigen might be lower than that recommended in the Japanese Urological Association Guidelines. An individualized and natural history-adjusted screening system should be established for screening participants with low prostate-specific antigen level.