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Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer: A Prospective Study.

NCT ID: NCT07144228Sponsor: Duke UniversityLast updated: 2026-03-19

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 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.

Arms & interventions

  • DeviceHeLP TM

    lab test for prostate cancer

Outcome measures

Primary

  • Levels of HeLP™ proteins in the platelets of patients suspected to have PCa

    Researchers will define the levels of HeLP™ proteins in the platelets of patients suspected to have PCa based on assessment within Duke Health compared to standard of care like PSA, mpMRI PI-RADS and other biomarkers (if available).

    Time frame: Baseline

  • Diagnostic accuracy as reported by area under the curve (AUC)

    Overall diagnostic accuracy of clinical variables including PSA, PI-RADS scoring, Hessian Map and other biomarkers (if available) will be determined and compared using receiving operating curve/area under curve analysis.

    Time frame: Baseline

Eligibility criteria

Sex: MaleAge: 40 Years and olderHealthy volunteers: No
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.

Study locations (1)

Duke University

Durham, North Carolina, 27710

Recruiting
Judd Moul, MD · Contact
919-684-5057judd.moul@duke.edu
Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer | Cancerify