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.
Age range
40 Years
Sex
MALE
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Levels of HeLP™ proteins in the platelets of patients suspected to have PCa
Timeframe: Baseline
Diagnostic accuracy as reported by area under the curve (AUC)
Timeframe: Baseline