Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer
Recruiting now
Conditions studied: Prostate Cancer (Diagnosis)
In brief
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.
Key facts
- Study ID
- NCT07144228
- Run by
- Duke University
- People needed
- 300
- Starts
- 2026-03-11
- Expected to finish
- 2028-09-30
- Last updated by the study team
- 2026-08-06
Who can join
Age: 40 and older. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- 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 is running
- Duke University — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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