Refining the Management of Prostate Imaging Reporting Category 3 Lesions through SelectMDx Urinary Biomarker Evaluation.

Petrino-Cristian Calinoiu, Daniel Badescu, Ovidiu-Catalin Nechita, Cristian-Valentin Toma, Diana Neculai, Stefan Rascu, Razvan-Cosmin Petca, Justin Aurelian, Cristian-Sorin Sima, Viorel Jinga
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Abstract

Objectives: 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.

Materials and methods: 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.

Results: 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.

通过SelectMDx尿液生物标志物评估改进前列腺影像报告3类病变的管理。
目的:本研究旨在评估SelectMDx尿液生物标志物检测在通过多参数磁共振成像(mpMRI)发现PI-RADS 3病变的男性中的临床应用,这是一个前列腺癌诊断仍不确定的亚组。主要目的是评估SelectMDx是否可以改善临床显著前列腺癌的风险分层,从而减少不必要的前列腺活检。材料与方法:对40例血清前列腺特异性抗原(PSA)水平≥3ng /mL、mpMRI上PI-RADS≥3个病变的患者进行前瞻性队列分析。所有参与者都接受了mpMRI,随后进行了靶向磁共振成像/经直肠超声(MRI/TRUS)融合引导活检和标准TRUS引导活检。活检前,直肠指检后收集尿液样本进行SelectMDx分析。该测试评估远端无同源盒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,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效果。结果:PI-RADS 3病变患者(n=40)中,SelectMDx结果与活检证实有临床意义的前列腺癌有显著相关性。在SelectMDx阳性的患者中,57.1%的患者被检测出有临床意义的癌症,而在阴性的患者中,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%,总体诊断准确率为77.5%。虽然年龄是多变量分析中唯一的独立预测因子,但SelectMDx显示出排除恶性肿瘤和支持更多选择性活检策略的强大潜力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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