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 biomarker.
The participation of 3D Signatures will determine a baseline of genomic instability for patients with prostate cancer, to provide follow-up monitoring information, as well as essential clinical data for the future development of blood-based tests. Those tests then can be used to provide tailored clinical assessment and treatment for patients with prostate cancer.
“The PRECISE trial aims to determine whether MRI, a non-invasive imaging test, can replace invasive prostate biopsies in men with an elevated PSA,” Klutz said in a recent press release. “We have an opportunity to test a new blood-based biomarker to accurately stratify patients into risk groups. If successful, this could represent a first-in-class blood test which would specifically identify clinically significant prostate cancer. Such a tool does not currently exist for prostate cancer patients,” he said.
The project is being supported by the Ontario Institute for Cancer Research (OICR) and the Movember Foundation Canada.