Proclarix blood test to identify clinically significant prostate cancer in a multi-ethnic US cohort

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

This study will test whether the Proclarix blood test can help detect clinically significant prostate cancer in men aged 40–75 who are scheduled for a prostate biopsy and have a PSA of 2–10 ng/mL.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 40 Years to 75 Years
• Sex: Male
• Sponsor: Sequenom, Inc. (industry)
• Locations: 1 site (Meridian, Idaho)
• Trial ID: NCT07543757 on ClinicalTrials.gov

What this trial studies

This is a prospective, multi-center, single-cohort US validation in up to 10 urology clinics where blood is collected before a scheduled prostate biopsy and analyzed with the Proclarix assay at Labcorp. Proclarix combines two protein biomarkers (THBS1 and CTSD) with total and free PSA and age to produce a risk score, and the lab samples are blinded to biopsy outcome. Biopsies are performed per local standard practice (systematic, targeted, or combined, transrectal or transperineal) with at least 10 cores and histopathology read locally; clinically significant prostate cancer (csPCa) is ISUP Grade Group ≥2. The study will compare Proclarix risk scores to biopsy results to validate performance in a multi-ethnic US population, building on previous European validations.

Who should consider this trial

Good fit: Men aged 40–75 who provide consent, have a standard-of-care total PSA between 2 and 10 ng/mL within 30 days, agree to provide blood, and are scheduled for a prostate biopsy within 30 days are eligible.

Not a fit: Men outside the 2–10 ng/mL PSA range, those not scheduled for biopsy, or men with known prior prostate cancer are unlikely to benefit from this validation study.

Why it matters

Potential benefit: If successful, Proclarix could help identify men at low risk of clinically significant prostate cancer and reduce unnecessary biopsies and overdiagnosis.

How similar studies have performed: Previous validations in European cohorts (955 men) reported ~90% sensitivity and 95% NPV but were majority Caucasian, so US multi-ethnic confirmation is still needed.

Eligibility criteria

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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Where this trial is running

Meridian, Idaho

• Idaho Urologic Institute — Meridian, Idaho, United States (RECRUITING)

Study contacts

• Study coordinator: Senior Clinical Trial Manager

Conditions: Prostate Cancer Detection, prostate cancer, screening