Research protocol for the evaluation of TriNetra™ prostate: a circulating tumor cell-based diagnostic tool for prostate cancer.

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.