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目的:探讨前列腺多参数磁共振(mpMRI)阴性患者诊断为有临床意义前列腺癌(CsPCa)的独立危险因素及风险分层方案。方法:回顾性分析2015年10月至2021年1月苏州大学附属第一医院、苏州大学附属第二医院、南京中医药大学附属昆山市中医院收治的前列腺mpMRI检查阴性且行系统穿刺的549例患者的临床资料。患者中位年龄67(62，73)岁，总前列腺特异性抗原(PSA)9.01(6.15，13.64)ng/ml，前列腺体积48.41(35.85，64.28)ml；其中直肠指检阳性54例。549例前列腺影像报告和数据系统(PI-RADS)评分≤2分，均行12针系统穿刺，其中278例经会阴穿刺，271例经直肠穿刺。以CsPCa为结局指标，对年龄、tPSA、f/tPSA以及PSA密度(PSAD)进行受试者工作特征(ROC)曲线分析，取最佳截断值，采用logistic回归分析mpMRI阴性患者诊断为CsPCa的独立危险因素。取mpMRI诊断CsPCa的阴性预测值(NPV)为100%时最佳截断值为保护因素，最终提出风险分层方案。结果:549例中前列腺癌79例，其中CsPCa 44例；非前列腺癌470例。CsPCa组与非CsPCa组患者年龄[71 (67，76)岁与67 (61，73)岁]、tPSA[11.95 (8.64，16.26) ng/ml与8.75 (6.06，13.24) ng/ml]、PSAD[0.31 (0.18，0.53) ng/(ml·cmn 3)与0.18 (0.12，0.18) ng/(ml·cmn 3)]、f/tPSA[0.12 (0.09，0.15)与0.16 (0.13，0.22)]、直肠指检阳性率[38.6%(17/44)与7.3%(37/505)]差异有统计学意义(n P65岁(n OR＝3.43, 95%n CI 1.55～7.58, n P＝0.002)、f/tPSA0.15 ng/(ml·cmn 3)(n OR＝3.60, 95%n CI 1.13～11.51, n P＝0.030)、直肠指检阳性(n OR＝5.20, 95%n CI 2.39～11.32, n P65岁、f/tPSA0.15 ng/(ml·cmn 3)和直肠指检阳性为mpMRI阴性患者诊断为CsPCa的独立危险因素。风险分层为高危组患者推荐行穿刺活检，低危组患者可以考虑避免穿刺。n “,”Objective:To explore independent risk factors and risk stratification for diagnosis of clinically significant prostate cancer (CsPCa) in biopsy-naive patients with nonsuspicious multiparametric magnetic resonance imaging (mpMRI).Methods:The data of 549 patients who underwent initial systematic biopsy (SB) in the First Affiliated Hospital of Soochow University, the Second Affiliated Hospital of Soochow University and Traditional Chinese Medicine Hospital of Kunshan between October 2015 and January 2021 were retrospectively reviewed. Nonsuspicious mpMRI was defined as Prostate Imaging-Reporting and Data System (PI-RADS)≤2. All patients received systematic 12 core prostate biopsy, 278 of them by transperineal and 271 by transrectal biopsies. The median age of the patients was 67 (62, 73) years, the median prostate specific antigen (PSA) was 9.01 (6.15, 13.64) ng/ml, the median prostate volume was 48.41 (35.85, 64.28) ml, and 54 patients were positive in digital rectal examination (DRE). Taking CsPCa as the outcome index, receiver operating characteristic (ROC) analysis was performed on age, tPSA, f/tPSA and PSA density (PSAD) to obtain the optimal cut-off value, and logistics regression was used to explore the independent risk factor of CsPCa in mpMRI negative patients. The optimal cut-off value when the negative predictive value (NPV) of mpMRI diagnosis of CsPCa was 100%, was taken as the protective factor, and the risk stratification model was finally proposed.Results:Of all 549 cases, 44 were CsPCa, 35 were clinically insignificant prostate cancer and 470 were non-prostate cancer. There were significant differences in age (71 vs. 67 years old), tPSA (11.95 vs. 8.75 ng/ml), PSAD [0.31 vs. 0.18 ng/(ml·cmn 3)], f/tPSA (0.12 vs. 0.16) and DRE positive rate (38.6% vs. 7.3%) between CsPCa group and non-CsPCa group (n P<0.01). Cut-off values were taken in ROC analysis when the Youden index was at its maximum. The optimal cut-off values of each continuous variable were: age=65 years, tPSA=10ng/ml, f/tPSA=0.2 and PSAD=0.15 ng/(ml·cmn 3). Multivariate analysis showed that ages over 65 years (n OR=3.43, 95%n CI 1.55-7.58, n P=0.002), f/t PSA ratio0.15 ng/(ml·cmn 3) (n OR=3.60, 95%n CI 1.13-11.51, n P=0.03) and positive DRE (n OR=5.20, 95%n CI 2.39-11.32, n P65 years, f/tPSA 0.15 ng/(ml·cmn 3) and DRE positive are independent risk factors of CsPCa in mpMRI negative patients. Patients in the high-risk group were recommended to undergo prostate biopsy, while patients in the low-risk group could be considered to avoid biopsy.n