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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.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Currently, doctors rely on multiple tests such as PSA, MRI scans and biopsies to do the same evaluation."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether HeLP™, a new blood test, can safely and accurately find prostate cancer and show how serious it is. It looks at proteins in platelets, the parts of blood that help it clot. The study is for men age 40 or older who may have 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 40 or older.
  • Being seen at Duke Health/Urology because doctors suspect prostate cancer.

Who can't join

  • Have been treated for prostate cancer before.
  • Have been diagnosed with prostate cancer before.
  • Have a severe blood-clotting problem that cannot be reversed.
  • Take anticoagulants, medicines that slow blood clotting.
  • Have taken medicines that affect platelets within 7 days before the blood draw. These include aspirin, NSAID pain medicines (such as ibuprofen or naproxen), clopidogrel, prasugrel, ticagrelor, or dipyridamole.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

NC