Platelet protein blood test for prostate cancer detection and monitoring
Official title: Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.
Run by Duke University · NCT07144228 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 40 Years and up |
| Sex | Men only |
| Enrollment | 300 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | March 11, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT07144228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Duke University
Durham, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Judd Moul, MD
- Email: judd.moul@duke.edu
- Phone: 919-684-5057
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
68Ga-XMFH01 PET/FL imaging to guide prostate cancer surgery
This study tests a new dual-modality imaging probe, 68Ga-XMFH01, to preoperatively detect prostate cancer and guide the surgeon with fluorescence during operations in adults with newly diagnosed prostate cancer.
-
Hugo Robotic Prostatectomy in an Ambulatory Surgery Center
This study tests the use of the Hugo robotic system for prostate removal in adult men treated at an outpatient surgical center.
-
Adaptive intraoperative biopsy system for prostate cancer using imaging and metabolic feedback
Aiming to test a smart biopsy approach that combines preoperative imaging with real-time metabolic signals to guide where to take prostate biopsy cores for better precision in men suspected of prostate cancer.
-
miRNA panel test to help diagnose prostate cancer
A blood test using a microRNA panel is being tested to help diagnose prostate cancer in men who are suspected of having the disease.
-
Testing 68Ga-NYM032 PET/CT in men with newly diagnosed prostate cancer
This study tests a new PSMA-targeted PET/CT imaging agent to see if it safely and accurately locates cancer in men who have just been diagnosed with prostate cancer and are planned for surgery.
-
Multi-Modal Imaging and Digital Pathology to Predict Clinically Significant Prostate Cancer
A multi-center study tests a deep learning model that combines MRI, ultrasound, and digital pathology to see if it can predict clinically significant prostate cancer non-invasively and help guide biopsies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.