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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer Detection
• Intervention / Treatment: Diagnostic test: Proclarix

Detailed 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 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. A software algorithm returns a risk score that can be used as an aid in the identification of clinically significant PCa (csPCa), defined as International Society of Urological Pathology (ISUP) Grade Group ≥ 2. Proclarix® has been developed and validated on 955 men, in majority of Caucasian background with 90% sensitivity, 43% specificity, 95% negative predictive value (NPV) and 25% positive predictive value (PPV). The validation performance established on German and Austrian patients has been fully confirmed in other European populations: the United Kingdom, Spain, Denmark, Italy and Switzerland.

To be used broadly, confirmation of Proclarix® performance in patients from diverse ethnic backgrounds requires further investigation.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Senior Clinical Trial Manager; Phone Number: 858-202-2000; Email: clinicalaffairsSD@labcorp.com

Study Locations

• United States
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Recruiting
      • Idaho Urologic Institute
      • Contact: Brian Mihm, LPN; Phone Number: 208-639-4946; Email: bmihm@idurology.com
      • Contact: Karrie Fox, BS; Phone Number: 208-639-4884; Email: karried@idurology.com
      • Principal Investigator: Joseph Williams, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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:

-

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prostate cancer suspected; Subjects with an elevated PSA (2-10) planning to undergo prostate biopsy	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Proclarix's clinical ability to correlate with and add to the results of other diagnostic tests performed as standard of care (i.e., MRI, ultrasound, etc.)	Compare study test results to SOC screening and diagnostic tests.	From enrollment to collection of biopsy results at 90 days

Collaborators and Investigators

• Sponsor: Sequenom, Inc.
• Collaborators: Labcorp Corporation of America Holdings, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: prostate cancer, screening
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SQNM-PRO-401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No