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

NCT07543757 | Recruiting

• 1 other identifier: SQNM-PRO-401
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer Detection

Keywords

prostate cancer, screening

Outcome Measures

Primary Outcomes (2)

• Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results.

  Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.

  From enrollment to the collection of prostate biopsy results at 90 days

• Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results

  Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.

  From enrollment to collection of biopsy results at 90 days

Study Arms (1)

Prostate cancer suspected

Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy

Diagnostic Test: Proclarix

Interventions

Proclarix DIAGNOSTIC_TEST

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.

Prostate cancer suspected

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Previous diagnosis of prostate cancer; 2. Treatment with a medication classified as a 5α-reductase-inhibitor at any time in the 6 months prior to study blood draw; 3. Acute or chronic urinary tract infection within 3 months of the Screening Visit; 4. Men with an indwelling catheter or intermittent self-catheterization; 5. Digital Rectal Exam (DRE) or transurethral manipulation (e.g. cystoscopy, catheterization) the same day and prior to the Screening Visit blood draw; 6. Men who had an invasive urological procedure for benign prostate hyperplasia/obstruction (e.g. transurethral resection of the prostate (TURP), Holmium Laser Enucleation of the Prostate (HoLEP), Thulium laser enucleation of the prostate (ThuLEP), aquablation, prostatic artery embolization, Rezum, laser vaporization, etc.) or biopsy of the prostate 6 months prior to the Screening Visit blood draw; 7. Subject is not able to read and comprehend English or Spanish; or 8. Previous enrollment in this protocol.

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.

Sponsors & Collaborators

• Sequenom, Inc.: lead
• Labcorp Corporation of America Holdings, Inc: collaborator

Study Sites (1)

Idaho Urologic Institute

Meridian, Idaho, 83642, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Senior Clinical Trial Manager

CONTACT

858-202-2000; clinicalaffairsSD@labcorp.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 22, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)