Purpose: Prostate-specific antigen (PSA) is a sensitive but unspecific marker for prostate cancer (PC) detection, which may result in harms including overdiagnosis and overtreatment. Therefore, the development of new markers is of absolute value. The urinary level of engrailed-2 (EN2) protein has been recently suggested as a promising PC biomarker, correlating with tumour volume and stage. This study evaluated EN2 and its potential use in clinical practice.Materials and methods: Urinary EN2 was assessed by different commercially available enzyme-linked immunosorbent assay kits. The study sample included 90 patients with clinically localized PC compared to 30 healthy controls, and a group of 40 patients indicated for prostate biopsy due to an elevated PSA level where both pre- and post-digital rectal examination urine samples were collected.Results: No statistical difference between the patient group and the control group was obtained in all measured variables. There was no significant correlation between urinary EN2 and serum PSA, tumour staging and grading. Attentive DRE did not lead to significant changes of urinary EN2 or impact on its predictive power.Conclusions: Our results show that EN2 as a PC biomarker brings no additional value to the current use of PSA in clinical practice.

中文翻译：

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Engrailed-2 (EN2) 是前列腺癌检测中真正有前景的生物标志物吗？

目的：前列腺特异性抗原（PSA）是一种敏感但非特异性的前列腺癌（PC）检测标志物，可能导致过度诊断和过度治疗等危害。因此，新标志物的开发具有绝对价值。尿 engrailed-2 (EN2) 蛋白水平最近被认为是一种很有前景的 PC 生物标志物，与肿瘤体积和分期相关。本研究评估了 EN2 及其在临床实践中的潜在用途。材料和方法：通过不同的市售酶联免疫吸附测定试剂盒评估尿液 EN2。研究样本包括 90 名临床局限性 PC 患者与 30 名健康对照者，以及一组 40 名因 PSA 水平升高而需要进行前列腺活检的患者，其中收集了直肠指检前和指检后的尿液样本。结果：在所有测量变量中，患者组和对照组之间没有获得统计学差异。尿EN2与血清PSA、肿瘤分期和分级之间没有显着相关性。细心的 DRE 不会导致尿 EN2 的显着变化或对其预测能力的影响。结论：我们的结果表明，EN2 作为 PC 生物标志物不会为当前 PSA 在临床实践中的使用带来额外的价值。