Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
Sequenom, Inc.
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)). A minimum of 10 cores is required if a systematic biopsy is performed. 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.
Description
Prostate cancer remains a leading cause of cancer-related morbidity and mortality in men worldwide, with significant disparities in incidence and outcomes across different ethnic groups with black men being affected by prostate cancer earlier, more frequently and with more aggressive disease. Current risk stratification tools often lack the precision needed to effectively assess and predict prostate cancer risk in diverse populations. Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It…
Eligibility
- Age range
- 40–75 years
- Sex
- Male
- Healthy volunteers
- No
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 90 days of the study blood draw; 4. Subject is presenting to the clinic to discuss a potential prostate biopsy; 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. 7 Study blood sample will be collected prior to MRI (if conducted) and prior to the biopsy. Exclusion Crite…
Interventions
- Diagnostic TestProclarix
Proclarix® is a blood-based test that addresses the problem of prostate cancer (PCa) overdiagnosis by indicating the risk of clinically significant disease. It is comprised of two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), and is combined with total prostate-specific antigen (tPSA), free PSA (fPSA) and age.
Locations (7)
- Om ResearchSan Diego, California
- Idaho Urologic InstituteMeridian, Idaho
- Graves Gilbert ClinicBowling Green, Kentucky
- Chesapeake Urology AssociatesHanover, Maryland
- Chesapeake Urology AssociatesTowson, Maryland
- Crystal Run HealthcareMiddletown, New York