An observational study in Prostate Cancer (Diagnosis), sponsored by Duke University. Recruiting at 1 site in United States. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Duke University · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
All subjects meeting eligibility criteria will be offered participation in this research study. The study is not relevant to women. The terminally ill subjects, students, children or volunteers-will not be included.
Eligibility criteria
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
Researchers are screening men who are suspicious of Pca, so those who will be negative for cancer will be the control group.
Device: HeLP TM
Researchers are screening men who are suspicious of Pca, so those who will be diagnosed will be the case group.
Device: HeLP TM
lab test for prostate cancer
Levels of HeLP™ proteins in the platelets of patients suspected to have PCa
Researchers will define the levels of HeLP™ proteins in the platelets of patients suspected to have PCa based on assessment within Duke Health compared to standard of care like PSA, mpMRI PI-RADS and other biomarkers (if available).
Time frame: Baseline
Diagnostic accuracy as reported by area under the curve (AUC)
Overall diagnostic accuracy of clinical variables including PSA, PI-RADS scoring, Hessian Map and other biomarkers (if available) will be determined and compared using receiving operating curve/area under curve analysis.
Time frame: Baseline
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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