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HeLP™ Test for Prostate Cancer Diagnosis and Monitoring

This study is evaluating a new blood test called HeLP™ that uses proteins from your platelets (tiny blood cells that help with clotting) to detect and monitor prostate cancer. Currently, doctors use tests like PSA (prostate-specific antigen), MRI scans, and biopsies. Researchers want to see if HeLP™ can be a safe and accurate alternative. You might be able to join if you are a man aged 40 or older and your doctor suspects you might have prostate cancer. The study will measure the levels of HeLP™ proteins in your blood to see how well it can diagnose prostate cancer. The study is currently recruiting participants.

Study design
This is an observational study, meaning participants will not receive an experimental treatment. It aims to enroll 300 men.
What's involved
If you join, the research team will take 3 extra tubes of blood (about 3 tablespoons) when you are already getting a repeat PSA test or imaging. This research test will not affect the care you are already receiving.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study, including HeLP™ protein levels and diagnostic accuracy, are taken at baseline (when you first join).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07144228

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

Recruiting
Not specifiedAges 40+Observational
Duke University
~300 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:HeLP TM

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Levels of HeLP™ proteins in the platelets of patients suspected to have PCa
Measured over Baseline
+1 more outcome measured

Conditions

Prostate Cancer (Diagnosis)

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

Judd Moul, MD
[email protected]
919-684-5057
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.

What this trial measures

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

    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).

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

    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.