Blood Test Using Platelet Proteins to Detect Prostate Cancer
Tests a platelet protein blood test in men evaluated for suspected prostate cancer.
Plain-language title generated from the registry record
Registry title: Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer
Key facts
- Where
- Durham, United StatesSee the site
Where in United States
- Duke UniversityDurham, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Duke University
- Trial code
- NCT07144228
- Record updated
- 4 November 2026
- Original description
This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease. Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation. Researchers are trying to see if HeLP™ can be a safe and accurate alternative.Read full original descriptionShow less
Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.
This is a single center study evaluating whether a new blood test based on platelet proteins rather than plasma proteins can improve detection of prostate cancer and evaluate the degree of serious disease. Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation. Researchers are trying to see if HeLP™ can be a safe and accurate alternative.
The study is inviting men who are being seen for suspicion of prostate cancer (based on symptoms or previous lab results). If they agree to be in the study, the research team will take a sample of their blood at the time they are getting a repeat PSA test or having Imaging. The research test does not affect the care they are already receiving and takes 3 extra tubes of blood (~3 tbsp).
The research team is aiming to include 300 participants total. They believe 278 people are needed to confidently compare results between people with and without prostate cancer.
They will do an interim analysis halfway through the study, once samples from 150 subjects have been collected.
The research is considered low risk-no more uncomfortable or dangerous than a blood draw. There is a risk of loss of privacy, but researchers are taking strong steps to protect privileged information. That includes proper data handling, secure, storage, and making sure the study team is trained in research ethics.
Exclusion: Men who have previously undergone treatment for prostate cancer; Men with prior diagnosis of prostate cancer; 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; Men with severe, irreversible coagulopathy.
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.