Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07144228
Status
Recruiting
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Conditions

  • Prostate Cancer (Diagnosis)

Eligibility Criteria

Sex
MALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HeLP TM — DEVICE
    lab test for prostate cancer

Study Details

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 Dates

Start date
Mar 11, 2026
Status verified
Aug 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2028

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Control Group
    Researchers are screening men who are suspicious of Pca, so those who will be negative for cancer will be the control group.
  • Arm: Case Group
    Researchers are screening men who are suspicious of Pca, so those who will be diagnosed will be the case group.

Primary Outcome Measure

Levels of HeLP™ proteins in the platelets of patients suspected to have PCa [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710
Judd Moul, MD
[email protected]
919-684-5057

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Duke University· Durham, NC

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