Aim: To assess the efficacy and limitation of free/total prostate-specific antigen ratio (f/tPSA) at a single institution in Japan, focusing on the avoidance of pointless prostate biopsies.

Methods: In total, 631 men between 44 and 93 years old (mean 69.8 years) with elevated PSA underwent power-Doppler ultrasoundgraphy-guided transrectal 10-core prostate biopsies at Niigata Cancer Center Hospital, and their histological features were investigated with total PSA (tPSA) and f/tPSA.

Results: PCa was detected in 126 of 134 patients (94.3%) with tPSA of 26 ng/mL or higher. The detection rate was 59.4% for tPSA of 21–25 ng/mL, followed by 39.2% for 16–20 ng/mL, 30.0% for 11–15 ng/mL, 20.0% for 4.1–10 ng/mL and 7.6% for 4.0 ng/mL. f/tPSA of the PCa group was significantly lower than that of non-malignamt disorders in any tPSA ranges (mean 0.122 vs. 0.160, P < 0.001). Receiver-operating characteristics analyses showed that f/tPSA (AUC: 0.664) performed more valuably than tPSA (AUC: 0.559) in patients with tPSA between 3.0–10 ng/mL (P < 0.01). Although f/tPSA of 0.250 for the cut-off value might miss 1.8% PCa patients, it potentially spares 9.2% of unnecessary biopsies.

Conclusion: f/tPSA is more valuable compared with tPSA alone for the prediction of the occurrence of PCa. We recommend 0.250 as the cut-off value for f/tPSA in PCa screening for Asian men having so-called grey-zone tPSA.

Keywords: prostate cancer screening, free/total prostate-specific antigen ratio, multi-site biopsy, single-institutional trial

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