Blood-Based Test to Detect, Monitor Prostate Cancer Will Be Used in Major Clinical Trial

Blood-Based Test to Detect, Monitor Prostate Cancer Will Be Used in Major Clinical Trial
3D Signatures announced that a major prostate cancer clinical trial will use its proprietary genome biomarker noninvasive blood-based test to diagnose and monitor prostate cancer patients. The clinical trial, named PRECISE, marks 3D Signatures' first step to validate and approve its clinical risk-assessment blood-based tests for prostate cancer. The 24-month, randomized, PRECISE clinical trial (NCT02380027) was designed to evaluate prostate cancer detection rates and monitoring efficiency using a magnetic resonance imaging (MRI)-targeted prostate biopsy, compared to standard prostate cancer biopsy assessment using 12-core trans-rectal ultrasound guided (TRUS). Both are surgical tools to diagnose and monitor patients with prostate cancer. The study is expected to enrol approximately 470 men who have not had prior biopsy, and who have clinical suspicion of prostate cancer. Each participant will be assigned randomly to one of the biopsy tests. The trial's main goal is the determine the proportion of men with clinically significant detected prostate cancer. PRECISE is being conducted in several clinical sites across Europe, and is currently recruiting participants. The study is being led by Laurence Klotz, MD, chairman of the Canadian Urology Research Consortium (CURC), the trial sponsor. The study also seeks to predict the most effective treatment plan for the individual patient by using 3D Signatures’ blood-based tests into the biopsy-focused examination as a correlative
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