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

NCT07543757 · tracked via the Priya Life Science USA tracker

Sponsor

Sequenom, Inc.

Phase

Observational

Started

2026-04-03

Last updated

2026-09-04

Condition(s) studied

Prostate Cancer Detection

Investigational drug(s) / intervention(s)

Proclarix

Proclarix: 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.

Study 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

Sex

MALE

Min age

40 Years

Max age

75 Years

Healthy volunteers

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: \-

Primary outcome measure(s)

Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results. — From enrollment to the collection of prostate biopsy results at 90 days
Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.

Trial sites (7)

Facility	City	Region	Status
Om Research	San Diego	California	Recruiting
Idaho Urologic Institute	Meridian	Idaho	Recruiting
Graves Gilbert Clinic	Bowling Green	Kentucky	Recruiting
Chesapeake Urology Associates	Hanover	Maryland	Recruiting
Chesapeake Urology Associates	Towson	Maryland	Recruiting
Crystal Run Healthcare	Middletown	New York	Recruiting
Carolina Urologic Research Center	Myrtle Beach	South Carolina	Recruiting

More Sequenom, Inc. trials in the USA

Compliant Analysis of Patient Samples and Data Enrolling by invitation

Specimen Collection from Patients with Non-Hematologic Cancer for Use in Development of a Liquid Biopsy Assay Recruiting

Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy Recruiting

Non-Invasive Preeclampsia Screening and Biobank Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07543757 on ClinicalTrials.gov ↗ ← All trials in the USA