Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Eligible age
40–75 yrs
Accepts
Men
Locations
5 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Sequenom, Inc.
You may qualify if…
- ✓ 1. Subject is male ≥40 and ≤75 years of age at the time of enrollment;
- ✓ 2. Subject provides a signed and dated informed consent;
- ✓ 3. Subject has a SOC tPSA of 2-10 ng/mL inclusive within 30 days of the Screening Visit;
- ✓ 1. Up to 100 subjects will have a SOC tPSA of 2-\<4 ng/mL
- ✓ 2. A minimum of 400 subjects will have a SOC tPSA of 4-10 ng/mL
- ✓ 4. Subject is scheduled to undergo a prostate biopsy within 30 days of the Screening Visit blood collection;
- ✓ 5. Subject agrees to provide all diagnostic test results throughout the study; and
- ✓ 6. Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.
You may not qualify if…
- ✕ \-
Where it's recruiting
Meridian
Bowling Green
Hanover · Towson
Middletown
Myrtle Beach
Source: ClinicalTrials.gov · NCT07543757 · last updated 2026-07-21