Combining Prostate Health Index density, magnetic resonance imaging and prior negative biopsy status to improve the detection of clinically significant prostate cancer
Combining Prostate Health Index density, magnetic resonance imaging and prior negative biopsy status to improve the detection of clinically significant prostate cancer
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DOI：
10.1111/bju.14098
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发表时间：
2018-04-01
影响因子：
4.5
通讯作者：
Pavlovich, Christian P.
中科院分区：
文献类型：
--
作者：
Druskin, Sasha C.;Tosoian, Jeffrey J.;Pavlovich, Christian P.
ObjectivesTo determine the performance of Prostate Health Index（PHI）density（PHID）combined with MRI and prior negative biopsy（PNB）status for diagnosis of clinically significant prostate cancer（PCa）.Patients and MethodsPatients without a prior diagnosis of PCa，with elevated prostate specific antigen and a normal digital rectal examination who encountered PHI testing prospectively before to prostate biopsy were included in this study.使用活检时经直肠超声检查得出的前列腺体积回顾性计算PHID。单变量和多变量逻辑回归模型，沿着受试者操作特征（ROC）曲线分析，用于确定血清生物标志物预测活检时临床显著PCa（定义为分级组[GG] ≥ 2疾病或在>2个核心或>50%的任何一个核心中检测到GG 1 PCa）的能力。年龄，PNB状态和前列腺成像报告和数据系统（PI-RADS）评分被纳入回归models.ResultsOf 241名男性谁有资格参加这项研究，91（37.8%）有临床意义的前列腺癌活检。中位（四分位距）PHID为0.74（0.44-1.24）;在活检时有和无临床显著PCa的患者中，PHID分别为1.18（0.77-1.83）和0.55（0.38-0.89）（P < 0.001）。在单变量logistic回归分析中，年龄和PNB状态与有临床意义的癌症相关。在测试的生物标志物中，PHID显示出对临床显著疾病的最高区分能力（单变量模型的ROC曲线下面积[AUC] 0.78）。在纳入年龄和PNB状态的多变量logistic回归模型中，情况仍然如此（AUC 0.82）。在阈值为0.44时，代表队列中PHID的第25百分位数，PHID对临床显著PCa的敏感性为92.3%，特异性为35.3%; GG ≥ 2和GG ≥ 3疾病的敏感性和特异性分别为93.0%和32.4%以及97.4%和29.1%。在接受MRI检查的104名男性中，PI-RADS评分与PHID互补，PI-RADS评分>= 3，或者如果PI-RADS评分= 0.44，则100%检测到临床显著疾病。对于该亚组，测试的生物标志物，PHID（AUC 0.90）表现出最高的判别能力，为临床显著疾病的多变量logistic回归纳入年龄，PNB状态和PI-RADS score.ConclusionsIn这个当代队列的男性前列腺活检的诊断PCa，PHID优于PHI和其他PSA衍生物在诊断临床显著癌症。年龄、PNB状态和PI-RADS评分的增加导致PHID诊断性能的进一步提高。此外，PI-RADS评分被认为是PHID的补充。使用0.44作为PHID的阈值，可以避免35.3%的不必要活检，代价是错过7.7%的临床显著癌症。尽管有这些令人鼓舞的结果，前瞻性验证是必要的。
ObjectivesTo determine the performance of Prostate Health Index (PHI) density (PHID) combined with MRI and prior negative biopsy (PNB) status for the diagnosis of clinically significant prostate cancer (PCa).Patients and MethodsPatients without a prior diagnosis of PCa, with elevated prostate-specific antigen and a normal digital rectal examination who underwent PHI testing prospectively prior to prostate biopsy were included in this study. PHID was calculated retrospectively using prostate volume derived from transrectal ultrasonography at biopsy. Univariable and multivariable logistic regression modelling, along with receiver-operating characteristic (ROC) curve analysis, was used to determine the ability of serum biomarkers to predict clinically significant PCa (defined as either grade group [GG] >= 2 disease or GG1 PCa detected in >2 cores or >50% of any one core) on biopsy. Age, PNB status and Prostate Imaging Reporting and Data System (PI-RADS) score were incorporated into the regression models.ResultsOf the 241 men who qualified for the study, 91 (37.8%) had clinically significant PCa on biopsy. The median (interquartile range) PHID was 0.74 (0.44-1.24); it was 1.18 (0.77-1.83) and 0.55 (0.38-0.89) in those with and without clinically significant PCa on biopsy, respectively (P < 0.001). On univariable logistic regression, age and PNB status were associated with clinically significant cancer. Of the tested biomarkers, PHID demonstrated the highest discriminative ability for clinically significant disease (area under the ROC curve [AUC] 0.78 for the univariable model). That continued to be the case in multivariable logistic regression models incorporating age and PNB status (AUC 0.82). At a threshold of 0.44, representing the 25th percentile of PHID in the cohort, PHID was 92.3% sensitive and 35.3% specific for clinically significant PCa; the sensitivity and specificity were 93.0% and 32.4% and 97.4% and 29.1% for GG >= 2 and GG >= 3 disease, respectively. In the 104 men who underwent MRI, PI-RADS score was complementary to PHID, with a PI-RADS score >= 3 or, if PI-RADS score = 0.44, detecting 100% of clinically significant disease. For that subgroup, of the biomarkers tested, PHID (AUC 0.90) demonstrated the highest discriminative ability for clinically significant disease on multivariable logistic regression incorporating age, PNB status and PI-RADS score.ConclusionsIn this contemporary cohort of men undergoing prostate biopsy for the diagnosis of PCa, PHID outperformed PHI and other PSA derivatives in the diagnosis of clinically significant cancer. Incorporating age, PNB status and PI-RADS score led to even further gains in the diagnostic performance of PHID. Furthermore, PI-RADS score was found to be complementary to PHID. Using 0.44 as a threshold for PHID, 35.3% of unnecessary biopsies could have been avoided at the cost of missing 7.7% of clinically significant cancers. Despite these encouraging results, prospective validation is needed.