Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix

Recruiting now

Conditions studied: Prostate Cancer Detection

In brief

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.

Key facts

Study ID

NCT07543757

Run by

Sequenom, Inc.

People needed

500

Starts

2026-04-03

Expected to finish

2027-03-31

Last updated by the study team

2026-07-21

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Subject is male ≥40 and ≤75 years of age at the time of enrollment;
• Subject provides a signed and dated informed consent;
• Subject has a SOC tPSA of 2-10 ng/mL inclusive within 30 days of the Screening Visit;
• Up to 100 subjects will have a SOC tPSA of 2-<4 ng/mL
• A minimum of 400 subjects will have a SOC tPSA of 4-10 ng/mL
• Subject is scheduled to undergo a prostate biopsy within 30 days of the Screening Visit blood collection;
• Subject agrees to provide all diagnostic test results throughout the study; and
• Subject agrees to provide blood for Proclarix® and phi testing at the Screening Visit.

Where it is running

• Idaho Urologic Institute — Meridian, Idaho, United States (enrolling)
• Graves Gilbert Clinic — Bowling Green, Kentucky, United States (enrolling)
• Chesapeake Urology Associates — Hanover, Maryland, United States (enrolling)
• Chesapeake Urology Associates — Towson, Maryland, United States (enrolling)
• Crystal Run Healthcare — Middletown, New York, United States (enrolling)
• Carolina Urologic Research Center — Myrtle Beach, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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