Gómez Rivas Juan, Mata Deniz Paula, Pischetola Arianna, Rodríguez Socarrás Moisés, Cuadros Rivera Vanesa, Gómez Sancha Fernando, Galante Isabel, Fernández Montarroso Lorena, Esperto Francesco, Moreno Sierra Jesús
Department of Urology, Health Research Institute, Hospital Clínico San Carlos, Madrid, Spain.
School of Medicine, Universidad Complutense de Madrid, Madrid, Spain.
Int J Surg Protoc. 2025 Jul 31;29(3):128-136. doi: 10.1097/SP9.0000000000000057. eCollection 2025 Sep.
Prostate cancer is one of the most prevalent malignancies among men, with early and accurate diagnosis is essential for optimizing clinical outcomes. The Trinetra-Prostate study is a prospective multicenter observational trial designed to evaluate the diagnostic performance of a novel blood-based test for detection of clinically significant prostate cancer. The test, developed by Datar Cancer Genetics, identifies circulating tumor cells (CTCs) in peripheral blood and is assessed against standard diagnostic modalities, including multiparametric magnetic resonance imaging and prostate biopsy. The primary objective of this study is to determine the sensitivity and specificity of the CTC assay for detecting cancer in men with elevated prostate-specific antigen levels and/or abnormal digital rectal examinations. Secondary objectives include assessing concordance with histopathological findings, potential to reduce unnecessary biopsies, and integration with existing diagnostic pathways. The study aims to enroll 250 men aged 45-75 years across multiple centers, applying the defined inclusion and exclusion criteria to ensure methodological rigor. The protocol includes detailed procedures for blood sampling, imaging, biopsy, and data analysis. Ethical approval was obtained and data protection measures are in place in accordance with international research standards. If validated, the CTC-based assay may offer a noninvasive and accurate alternative to current diagnostic approaches, improving patient stratification and reducing the burden of invasive procedures in prostate cancer diagnostics.
前列腺癌是男性中最常见的恶性肿瘤之一，早期准确诊断对于优化临床结果至关重要。Trinetra-前列腺研究是一项前瞻性多中心观察性试验，旨在评估一种新型血液检测方法对临床显著性前列腺癌的诊断性能。该检测方法由Datar癌症遗传学公司开发，可识别外周血中的循环肿瘤细胞（CTC），并与包括多参数磁共振成像和前列腺活检在内的标准诊断方法进行对比评估。本研究的主要目的是确定CTC检测法在检测前列腺特异性抗原水平升高和/或直肠指检异常的男性中癌症的敏感性和特异性。次要目的包括评估与组织病理学结果的一致性、减少不必要活检的可能性以及与现有诊断途径的整合。该研究旨在多个中心招募250名年龄在45至75岁之间的男性，应用明确的纳入和排除标准以确保方法的严谨性。该方案包括血液采样、成像、活检和数据分析的详细程序。已获得伦理批准，并根据国际研究标准采取了数据保护措施。如果得到验证，基于CTC的检测方法可能为当前诊断方法提供一种非侵入性且准确的替代方法，改善患者分层并减轻前列腺癌诊断中侵入性程序的负担。
