Calinoiu Petrino-Cristian, Badescu Daniel, Nechita Ovidiu-Catalin, Toma Cristian-Valentin, Neculai Diana, Rascu Stefan, Petca Razvan-Cosmin, Aurelian Justin, Sima Cristian-Sorin, Jinga Viorel
Department of Urology, "Prof. Dr. Th. Burghele" Clinical Hospital, Bucharest, Romania.
Department of Urology, "Carol Davila" University of Medicine and Pharmacy, Bucharest, Romania.
Maedica (Bucur). 2025 Jun;20(2):176-181. doi: 10.26574/maedica.2025.20.2.176.
This study aimed to evaluate the clinical utility of the SelectMDx urinary biomarker test in men with PI-RADS 3 lesions identified through multiparametric magnetic resonance imaging (mpMRI), a subgroup in which prostate cancer diagnosis remains uncertain. The primary objective was to assess whether SelectMDx can improve risk stratification for clinically significant prostate cancer and thereby reduce unnecessary prostate biopsies.
A prospective cohort of 40 patients with serum prostate-specific antigen (PSA) levels ≥3 ng/mL and PI-RADS ≥ 3 lesions on mpMRI was analyzed. All participants underwent mpMRI, followed by targeted magnetic resonance imaging/transrectal ultrasound (MRI/TRUS) fusion-guided biopsy and standard TRUS-guided biopsy. Prior to biopsy, urine samples were collected post-digital rectal examination for SelectMDx analysis. The test evaluates messenger ribonucleic acid (mRNA) expression of distal-less homeobox 1 (DLX1) and homeobox C6 protein (HOXC6), integrating molecular data with clinical parameters to generate individualized risk scores. Diagnostic performance was assessed through sensitivity, specificity, predictive values and logistic regression analyses.
Among patients with PI-RADS 3 lesions (n=40), a significant correlation between SelectMDx results and biopsy-confirmed clinically significant prostate cancer was observed. Clinically significant cancer was detected in 57.1% of patients with a positive SelectMDx result, compared to 18.2% in those with a negative result (p=0.031). The test demonstrated a sensitivity of 57.14%, a specificity of 81.82%, a positive predictive value of 40% and a negative predictive value of 90%, with an overall diagnostic accuracy of 77.5%. While age emerged as the only independent predictor in multivariate analysis, SelectMDx showed a strong potential to exclude malignancy and support more selective biopsy strategies.
本研究旨在评估SelectMDx尿液生物标志物检测在经多参数磁共振成像（mpMRI）检查发现PI-RADS 3类病变的男性中的临床应用价值，这是一个前列腺癌诊断仍不明确的亚组。主要目的是评估SelectMDx能否改善临床显著性前列腺癌的风险分层，从而减少不必要的前列腺活检。
对40例血清前列腺特异性抗原（PSA）水平≥3 ng/mL且mpMRI检查显示PI-RADS≥3类病变的患者进行前瞻性队列分析。所有参与者均接受了mpMRI检查，随后进行靶向磁共振成像/经直肠超声（MRI/TRUS）融合引导活检和标准TRUS引导活检。在活检前，于直肠指检后收集尿液样本进行SelectMDx分析。该检测评估远端同源盒1（DLX1）和同源盒C6蛋白（HOXC6）的信使核糖核酸（mRNA）表达，将分子数据与临床参数相结合以生成个体化风险评分。通过敏感性、特异性预测值和逻辑回归分析评估诊断性能。
在PI-RADS 3类病变患者（n = 40）中，观察到SelectMDx检测结果与活检确诊的临床显著性前列腺癌之间存在显著相关性。SelectMDx检测结果为阳性的患者中，57.1%检测到临床显著性癌症，而检测结果为阴性的患者中这一比例为18.2%（p = 0.031）。该检测的敏感性为57.14%，特异性为81.82%，阳性预测值为40%，阴性预测值为90%，总体诊断准确性为77.5%。虽然年龄在多变量分析中是唯一的独立预测因素，但SelectMDx显示出强大的排除恶性肿瘤的潜力，并支持更具选择性的活检策略。
