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

NCT07144228 | Recruiting FDA Device

• 1 other identifier: Pro00116819
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Prostate Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline

Study Arms (2)

Control Group

Researchers are screening men who are suspicious of Pca, so those who will be negative for cancer will be the control group.

Device: HeLP TM

Case Group

Researchers are screening men who are suspicious of Pca, so those who will be diagnosed will be the case group.

Device: HeLP TM

Interventions

HeLP TM DEVICE

lab test for prostate cancer

Case Group; Control Group

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: The study is not relevant to women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects meeting eligibility criteria will be offered participation in this research study. The study is not relevant to women. The terminally ill subjects, students, children or volunteers-will not be included.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• Hessian Labs Inc: collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Judd Moul, MD

CONTACT

919-684-5057; judd.moul@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: March 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)