Condition: Prostate Cancer Detection · Sponsor: Sequenom, Inc.
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent and prior to the scheduled prostate biopsy (≤30 days), up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. Prostate biopsy will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores are required. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy. The assay results will be compared to the biopsy results.
This description comes directly from the study's public registry record.
Senior Clinical Trial Manager · 858-202-2000 · clinicalaffairsSD@labcorp.com
Always discuss trial participation with your own doctor first.
| Idaho Urologic Institute | Meridian, Idaho, United States | Recruiting |
| Graves Gilbert Clinic | Bowling Green, Kentucky, United States | Recruiting |
| Chesapeake Urology Associates | Hanover, Maryland, United States | Recruiting |
| Chesapeake Urology Associates | Towson, Maryland, United States | Recruiting |
| Crystal Run Healthcare | Middletown, New York, United States | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach, South Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07543757