Status:
NOT_YET_RECRUITING
Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer
Lead Sponsor:
Duke University
Collaborating Sponsors:
Hessian Labs Inc
Conditions:
Prostate Cancer (Diagnosis)
Eligibility:
MALE
40+ years
Brief Summary
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 dis...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07144228
Start Date
December 15 2025
End Date
September 30 2028
Last Update
November 25 2025
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