Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix (NCT07543757)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Idaho Urologic Institute — Meridian, Idaho
Age range: 40 Years to 75 Years
🧪 Interventions in This Study
- Proclarix (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (6 Sites)
- Idaho Urologic Institute — Meridian, Idaho
- Graves Gilbert Clinic — Bowling Green, Kentucky
- Chesapeake Urology Associates — Hanover, Maryland
- Chesapeake Urology Associates — Towson, Maryland
- Crystal Run Healthcare — Middletown, New York
- Carolina Urologic Research Center — Myrtle Beach, South Carolina
📞 Contact the Study Coordinator
Phone: (858) 202-2000
Email: clinicalaffairsSD@labcorp.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Prostate Cancer Detection
- CEST for Prostate Biopsy — Toronto, Ontario
Explore by condition: All Prostate Cancer Detection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.