目的: 探讨靶向穿刺联合区域系统穿刺对前列腺影像和数据评分系统2.1版本(prostate imaging reporting and data system，PI-RADS v2.1)4~5分患者的前列腺癌(prostate cancer，PCa)诊断效能。方法: 前瞻性收集2023年1—10月于北京大学第一医院初次行前列腺穿刺活检, 总前列腺特异性抗原(total prostate specific antigen，tPSA)≤20 ng/mL且磁共振检查PI-RADS 4~5分的患者，行经直肠认知融合靶向穿刺(3针)和系统穿刺(12针)，选取不同穿刺位点定义多种假设穿刺方案, 比较靶向穿刺联合区域系统穿刺与其他穿刺方案对PCa检出效果的差异。结果: 共纳入255例患者，其中检出前列腺腺癌204例(80.0%)，临床有意义前列腺癌(clinically significant prostate cancer，csPCa)187例(73.3%)。靶向穿刺的PCa检出率显著低于靶向穿刺联合12针系统穿刺(77.3% vs. 80.0%，P=0.016)，漏诊患者中71.4%(5/7)为csPCa；靶向穿刺联合4针区域系统穿刺与联合12针系统穿刺相比，检出率差异无统计学意义(P>0.999)，漏诊csPCa及临床无意义前列腺癌(clinically insignificant prostate can-cer，cisPCa)各1例。靶向穿刺联合区域系统穿刺与联合外侧或传统6分区系统穿刺相比具有更少穿刺针数及更高的阳性针数占比。靶向穿刺漏诊与病灶最大径相关(OR=0.086，95%CI：0.013~0.562，P=0.010)。对于PI-RADS 5分患者，单纯靶向穿刺在122例中仅漏诊1例PCa；对于PI-RADS 4分患者，单纯靶向穿刺在133例中漏诊6例PCa，靶向穿刺联合区域系统穿刺漏诊csPCa及cisPCa各1例。结论: 靶向穿刺联合区域系统穿刺在PI-RADS评分为4~5分患者中具有较高诊断效能，可作为目前靶向穿刺联合12针系统穿刺的改良方案之一。对于PI-RADS 5分患者单纯靶向穿刺同样可行。

Objective: To investigate the diagnostic efficacy of targeted biopsy combined with regional systematic biopsy in prostate cancer (PCa) in patients with prostate imaging reporting and data system v2.1 (PI-RADS v2.1) 4-5. Methods: From January 2023 to October 2023, patients who underwent prostate biopsy for the first time with total prostate specific antigen (tPSA) ≤ 20 ng/mL and had a multi-parametric magnetic resonance imaging (mpMRI) PI-RADS of 4-5 in Peking University First Hospital were prospectively collected. All the patients underwent transrectal ultrasound-guided cognitive fusion targeted biopsy (3 cores) followed by systematic biopsy (12 cores). Various hypothetical biopsy schemes were defined based on different biopsy sites. The detection effectiveness of targeted biopsy combined with regional systematic biopsy and other biopsy schemes for prostate cancer were compared using Cochran's Q and McNemar tests. Results: A total of 255 patients were enrolled, of whom 204 (80.0%) were detected with prostate adenocarcinoma and 187 (73.3%) were clinically significant with prostate cancer (csPCa). The detection rate of PCa with targeted biopsy was significantly lower than that of targeted biopsy combined with 12-core system biopsy (77.3% vs. 80.0%, P=0.016), and 71.4% (5/7) of the missed patients was csPCa. There was no significant difference in the detection rate between targeted biopsy combined with 4-core regional system biopsy and 12-core system biopsy (P>0.999), and 1 case of csPCa and clinically insignificant prostate cancer (cisPCa) were missed. There was no significant difference in the detection rate of PCa between targeted combined regional system biopsy and targeted combined lateral or traditional 6-core system biopsy and the number of cores were reduced. Missed diagnosis of targeted biopsy was correlated with the maximum diameter of the lesion (OR=0.086, 95%CI: 0.013-0.562, P=0.010). For the patients with PI-RADS 5, only 1 case of PCa was missed in 122 cases by targeted biopsy alone. For patients with PI-RADS 4, 6 PCa cases were missed among the 133 patients with targeted biopsy alone, and 1 case of csPCa and cisPCa were missed by targeted biopsy combined with regional system biopsy. The statistics of positive core counts for different biopsy schemes indicated that targeted combined regional systematic biopsy had a higher proportion of positive cores second only to targeted biopsy alone. Conclusion: Targeted biopsy combined with regional systematic biopsy has high diagnostic efficacy in patients with PI-RADS 4-5 and can be considered as one of the improved schemes for combined biopsy. Targeted biopsy alone is also a feasible option for patients for patients with a PI-RADS score of 5.