NCT07543757 · Sequenom, Inc.
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
(PRIME)
What this study is about
The study is a forward-looking, multi-center, single group of participants 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Meridian, Idaho
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations