Platelet protein blood test for prostate cancer detection and monitoring
Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.
Duke University · NCT07144228
This study will test whether a blood test that looks at platelet proteins can detect and track prostate cancer in men being checked for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT07144228 on ClinicalTrials.gov |
What this trial studies
This single-center observational study at Duke University will collect three tubes of blood from up to 300 men being evaluated for possible prostate cancer and run the HeLP™ platelet proteomic assay alongside routine PSA testing and imaging. Blood samples are drawn during a scheduled PSA, biomarker test, or imaging visit and do not change the participant's clinical care. Researchers will compare HeLP™ results to diagnostic outcomes such as biopsy, imaging, and PSA to see if the platelet-based test can identify cancer and indicate disease severity, with an interim analysis planned at the halfway point. Men with prior prostate cancer diagnosis or treatment, severe coagulopathy, or recent anticoagulant/antiplatelet use are excluded to avoid confounding the platelet signal.
Who should consider this trial
Good fit: Men aged 40 years or older who are being seen at Duke Health for suspicion of prostate cancer and have not had prior prostate cancer treatment are the intended participants.
Not a fit: Men who have already been diagnosed or treated for prostate cancer, or who have taken anticoagulant or antiplatelet drugs within seven days of blood collection, are unlikely to benefit from this test or be eligible for the study.
Why it matters
Potential benefit: If successful, the test could reduce unnecessary biopsies and better identify men with more serious prostate cancer.
How similar studies have performed: Platelet-based liquid biopsy approaches are relatively novel; there is early promising work in other cancers and pilot data, but platelet proteomic assays for prostate cancer are not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility criteria * Patients ≥ 40 years of age * All patients with suspicion of PCa Men ≥ 40 years of age attending Duke Health/Urology with suspicion of prostate cancer (Primary disease) will be approached to consent for the study. Upon consent, samples will be obtained alone, during repeat PSA/other biomarkers testing, or during imaging at Duke Lab. Exclusion criteria * Men who have previously undergone treatment for prostate cancer. * Men with prior diagnosis of prostate cancer. * Men with severe, irreversible coagulopathy. * Men on anticoagulant therapies or those who have taken antiplatelet agents such as aspirin, NSAIDs (ibuprofen, entrophen, naproxen, diclofenac etc), clopidrogel, prasugrel, ticagrelor, or dipyridamole in the 7 days preceding blood collection.
Where this trial is running
Durham, North Carolina
- Duke University — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Judd Moul, MD
- Email: judd.moul@duke.edu
- Phone: 919-684-5057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer