Objective: The aim of this study was to investigate whether it was necessary to increase the number of cores at initial prostate biopsy with patients of prostate-specific antigen (PSA) ≥ 20 ng/mL and to explore an appropriate individual-ized transrectal ultrasonograhpy (TRUS)-guided prostate biopsy for the detection of prostate cancer in men suspicious of prostate cancer.Methods:A total of 115 patients with PSA ≥ 20 ng/mL and suspicious of prostate cancer were prospectively randomized to perform TRUS-guided biopsy. Patients were randomized to a “6 + X” cores or a “10 + X” cores protocol. The primary end point was cancer detection rate. Secondary end points were cancer characteristics, rate of complications and the level of pain experienced by patients during TRUS-guided prostate biopsy.Results:Preoperative variables were similar in both groups. The overal prostate cancer detection rate was 73.9%. The “10 + X” cores strategy increased cancer detection rate only 9.7% in patients with PSA ≥ 20 ng/mL but < 50 ng/mL, while there was no diference between the two strategies for cancer detection in patients with PSA ≥ 50.1 ng/mL. The number of extended biopsy cores and pain score of extended biopsy in prostate cancer patients increased significantly (P < 0.001).Conclusion:Our findings suggest that there is no significant advantage in using extended biopsy protocol in al patients with PSA ≥ 20 ng/mL.