Recruiting

Proclarix Assay

Sponsor:

Sequenom, Inc.

Code:

NCT07543757

Conditions

Prostate Cancer Detection

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Proclarix

Study Details

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

Study ID

NCT07543757

Start date

Apr 3, 2026

Status verified date

Sep, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Prostate cancer suspected

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

Interventions

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.

Primary outcome measure

  • Assess the clinical performance of Proclarix® in a United States (US) cohort when compared to the biopsy results. [ Time Frame: From enrollment to the collection of prostate biopsy results at 90 days ]

Central Contacts and Locations

Central contacts

Senior Clinical Trial Manager

858-202-2000clinicalaffairsSD@labcorp.com

Locations

Om Research

Recruiting

San Diego, California, United States, 92123

Contacts

Katie Golshan

858-429-7050kgolshan@omclinicaltrials.com

Alanna Gavriushina

858-429-7050alanna.gavriushina@uniohp.com

Principal Investigator:

Arman Walia, MD

Idaho Urologic Institute

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Brian Mihm, LPN

208-639-4946bmihm@idurology.com

Karrie Fox, BS

208-639-4884karried@idurology.com

Principal Investigator:

Joseph Williams, MD

Graves Gilbert Clinic

Recruiting

Bowling Green, Kentucky, United States, 42101

Contacts

Christian Jones

716-249-6700cjones@circuitclinical.com

Tanya Atkins

716-249-6700tatkins@circuitclinical.com

Principal Investigator:

Diego Mastronardi, MD

Chesapeake Urology Associates

Recruiting

Hanover, Maryland, United States, 21076

Contacts

Barbara Kyei

410-760-9400bkyei@chesuro.com

Principal Investigator:

Kaiser Robertson, MD

Chesapeake Urology Associates

Recruiting

Towson, Maryland, United States, 21204

Contacts

Tawni Doliveira

410-825-5454tawni.doliveira@chesuro.com

Principal Investigator:

Brian Neuman, MD

Crystal Run Healthcare

Recruiting

Middletown, New York, United States, 10941

Contacts

Dalea Frank

716-249-6700dfrank@circuitclinical.com

Lisa Crespi

716-249-6700lcrespi@circuitclinical.com

Principal Investigator:

Steve Rowe, MD

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

Contacts

Matt Parton

843-839-1679matthew.parton@startresearch.com

Jennifer Smith

843-839-1679jennifer.smith@startresearch.com

Principal Investigator:

Neil Shore, MD

More Information

Sponsor

Sequenom, Inc.

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • prostate cancer, screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sequenom, Inc. on 2026-09-04.