Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku od 40 do 75 lat
- •Wyraźna zgoda na uczestnictwo w badaniu
- •Poziom PSA (markera prostaty) między 2-10 ng/mL zmierzony w ciągu 30 dni przed włączeniem
- •Zaplanowana biopsja prostaty w ciągu 30 dni od pobrania krwi
- •Zgoda na udostępnienie wszystkich wyników badań diagnostycznych
- •Zgoda na pobranie krwi do testów Proclarix i phi
Simplified criteria — AI translation
Trial details
- Minimum age
- 40 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 21, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (6)
Idaho Urologic Institute
Meridian, United States
Graves Gilbert Clinic
Bowling Green, United States
Chesapeake Urology Associates
Hanover, United States
Chesapeake Urology Associates
Towson, United States
Crystal Run Healthcare
Middletown, United States
Carolina Urologic Research Center
Myrtle Beach, United States
Trial contact
Senior Clinical Trial Manager
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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