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

Duke University

Status

Not yet enrolling

Conditions

Prostate Cancer (Diagnosis)

Treatments

Device: HeLP TM

Study type

Observational

Funder types

Other

Identifiers

NCT07144228

Pro00116819

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.