Objective：The current study aims to compare the diagnostic efficacy of prostate targeted biopsy alone and targeted combined system biopsy in patients with high prostate imaging reporting and data system(PI-RADS)score of 4~5. Methods： Between July 1，2019 and June 1，2022，439 patients with prostate PI-RADS score of 4-5 who received prostate targeted biopsy alone and targeted combined system biopsy in the First Affiliated Hospital of Nanjing Medical University were retrospectively analyzed. Two urologists independently performed biparametric magnetic resonance imaging-transrectal ultrasonography(bpMRI-TRUS)assisted targeted biopsy and targeted combined system biopsy in each patient. The detection of clinically significant prostate cancer(CsPCa)by different biopsy methods were compared by χ2 test or Fisher’s exact test. Results：The detection rate of CsPCa by targeted biopsy was lower than that by targeted combined system biopsy，but the difference was not statistically significant(P=0.05). If only targeted biopsy was performed，5.0% of CsPCa would be missed. In patients with a PI-RADS score of 4，the detection rate of CsPCa by targeted biopsy was lower than that by targeted combined system biopsy，the difference was statistically significant(P＜0.05). If only targeted biopsy was performed，6.2% of CsPCa would be missed. When 0＜PSA ≤20 ng/mL，the detection rate of CsPCa by targeted biopsy was lower than that by targeted combined system biopsy，the difference was statistically significant(P＜0.05)；but when 20 ng/mL＜PSA≤50 ng/mL， the difference was not statistically significant(P＞0.05). In patients with a PI-RADS score of 5，the detection rate of CsPCa by targeted biopsy was lower than that by targeted combined system biopsy，while the difference was not statistically significant(P＞0.05). If only targeted biopsy was performed，3.5% of CsPCa would be missed. In PSA subgroup analysis，there was also no significant difference in the detection rate of CsPCa between the two methods(P＞0.05). The coincidence rate between targeted biopsy and radical postoperative pathology was slightly lower than that of targeted combined system biopsy group，but the difference was not statistically significant(P＞0.05). In PI- RADS score subgroup and PSA stratification analysis，there were also no significant difference in the coincidence rate between targeted biopsy and targeted combined system biopsy(P＞0.05). Conclusion：For patients with suspected high-risk prostate cancer with a PI-RADS score of 4-5，when PI-RADS score is 4 and PSA ＞ 20 ng/mL or PI-RADS score is 5，a single targeted biopsy may replace the targeted combined system biopsy
