Prostate Cancer Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
North Carolina
Duke University
RECRUITING
Durham
Contact Information
Primary
Judd Moul, MD
judd.moul@duke.edu
919-684-5057
Time Frame
Start Date: 2026-03-11
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 300
Treatments
Control Group
Researchers are screening men who are suspicious of Pca, so those who will be negative for cancer will be the control group.
Case Group
Researchers are screening men who are suspicious of Pca, so those who will be diagnosed will be the case group.
Related Therapeutic Areas
Sponsors
Collaborators: Hessian Labs Inc
Leads: Duke University

This content was sourced from clinicaltrials.gov