Actively Recruiting
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Led by Sequenom, Inc. · Updated on 2026-04-22
500
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
S
Sequenom, Inc.
Lead Sponsor
L
Labcorp Corporation of America Holdings, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 40 to 75 years at enrollment
- Signed and dated informed consent provided
- Have a standard of care total PSA (tPSA) between 2 and 10 ng/mL within 30 days of screening
- Scheduled for a prostate biopsy within 30 days of blood collection
- Agree to provide all diagnostic test results during the study
- Agree to provide blood for Proclarix�ae and phi testing at screening
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 1 location
1
Idaho Urologic Institute
Meridian, Idaho, United States, 83642
Actively Recruiting
Research Team
S
Senior Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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