The purpose of this study was to assess the efficacy, specificity, and predictive value of a newly discovered biomarker, Zinc finger-like1 protein (referred to as neuroendocrine marker, NEM) for the detection of prostate cancer (PCa). We retrospectively analyzed banked plasma samples from 508 men, with a median age of 67 years (range 48–97), to compare the performance of NEM and PSA in predicting subsequent histologic PCa. The cohort consisted of four groups of patients visiting a urology clinic: (1) patients not diagnosed with either benign prostatic disease or prostate cancer (PCa) were defined as normal; (2) patients diagnosed with benign hyperplasia (BPH) but not PCa; (3) patients with confirmed PCa; and (4) patients with cancer other than PCa. The normal men displayed a mean NEM plasma level of 0.948 ± 0.051 ng/mL, which increased to 1.813 ± 0.315 ng/mL in men with BPH, 86.49 ± 15.51 ng/mL in men with PCa, and 10.47 ± 1.029 ng/mL in men with other Ca. The corresponding concentrations of prostate-specific antigen (PSA) in these subjects were 1.787 ± 0.135, 5.405 ± 0.699, 35.77 ± 11.48 ng/mL, and 8.036 ± 0.518, respectively. Receiver operating characteristic (ROC) curve analysis was performed to compare NEM and PSA performance, and the Jouden Index for each biomarker was calculated to determine cut-off points for each biomarker. The area under the ROC curve to predict PCa was 0.99 for NEM and 0.81 for PSA (p< 0.0001). The cut-off for NEM was at 1.9 ng/mL, with sensitivity of 98% and specificity of 97%. The corresponding PSA values were 4.4 ng/mL, with sensitivity of 76% and specificity of 95%. The predictive value of each biomarker in a patient was matched with his pathologic data to determine the accuracy of each biomarker. NEM was more accurate than PSA in differentiating cancer from benign conditions, such as BPH or prostatitis. In conclusion, NEM was a better predictor of PCa than PSA in patients visiting urology clinics. NEM tests, either alone or in conjunction with other biomarkers, provide a reliable, non-invasive, and inexpensive test to remarkably reduce false positives and thereby reduce the number of diagnostic biopsies and associated painful procedures and the loss of quality of life.
本研究旨在评估新发现的生物标志物锌指样蛋白1（简称神经内分泌标志物NEM）在前列腺癌（PCa）检测中的效能、特异性及预测价值。我们回顾性分析了508例男性（中位年龄67岁，范围48-97岁）的储存血浆样本，比较NEM与前列腺特异性抗原（PSA）在预测后续组织学前列腺癌方面的表现。研究队列包含泌尿科门诊的四组患者：（1）未诊断为良性前列腺疾病或前列腺癌者定义为正常组；（2）诊断为良性前列腺增生（BPH）但未患前列腺癌者；（3）确诊前列腺癌者；（4）患有非前列腺癌的其他癌症患者。正常组男性血浆NEM平均浓度为0.948±0.051 ng/mL，BPH组升至1.813±0.315 ng/mL，前列腺癌组达86.49±15.51 ng/mL，其他癌症组为10.47±1.029 ng/mL。上述各组对应的PSA浓度分别为1.787±0.135、5.405±0.699、35.77±11.48 ng/mL和8.036±0.518 ng/mL。通过受试者工作特征（ROC）曲线分析比较NEM与PSA性能，并计算各标志物的约登指数以确定截断值。预测前列腺癌的ROC曲线下面积NEM为0.99，PSA为0.81（p<0.0001）。NEM截断值为1.9 ng/mL时，敏感度为98%，特异度为97%；PSA截断值为4.4 ng/mL时，敏感度为76%，特异度为95%。将各标志物的预测值与患者病理数据进行匹配以评估准确性，结果显示NEM在区分癌症与BPH或前列腺炎等良性病变方面优于PSA。结论：在泌尿科门诊患者中，NEM较PSA具有更好的前列腺癌预测能力。NEM检测单独或联合其他标志物使用，可提供可靠、无创且经济的检测手段，显著降低假阳性率，从而减少诊断性活检数量及相关痛苦操作，改善患者生活质量。
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