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

Summary

The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, 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. If a prostate biopsy is performed, it 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)).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Prostate Cancer Detection

Eligibility basics and study details

Study type

Observational

Phase

Not applicable

Ages

40 to 75 years

Sex

Male

Healthy volunteers

Not accepted

Sponsor

Sequenom, Inc.

Last updated on ClinicalTrials.gov

September 28, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites