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 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.

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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Conditions2

Locations1 site

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