NCT07144228

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.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DEVICE	HeLP TM	lab test for prostate cancer

Timeline

• Start date: 2026-03-11
• Primary completion: 2026-09-30
• Completion: 2028-09-30
• First posted: 2025-08-27
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study