NCT07144228 · Duke University
Validation of a Platelet Proteomic Assay for Diagnosing and Monitoring Prostate Cancer
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
HeLP TM
lab test for prostate cancer
Primary outcome measures
Levels of HeLP™ proteins in the platelets of patients suspected to have PCa
Time frame: Baseline
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)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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.
Where
- Durham, North Carolina
Collaborators
Hessian Labs Inc
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations