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

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.

NCT Number	NCT07144228
Lead Sponsor	Duke University Collaborators: Hessian Labs Inc
Conditions	Prostate Cancer (Diagnosis)
Enrollment	300 participants
Start Date	2026-03-11
Primary Completion	2026-09-30 (estimated)
Study Completion	2028-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-06