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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer (Diagnosis)
• Intervention / Treatment: Device: HeLP TM

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Judd Moul, MD; Phone Number: 919-684-5057; Email: judd.moul@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
      • Contact: Judd Moul, MD; Phone Number: 919-684-5057; Email: judd.moul@duke.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; lab test for prostate cancer
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; lab test for prostate cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Hessian Labs Inc

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: August 20, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Actual): August 27, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease
• Other Study ID Numbers: Pro00116819

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes