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Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
Sponsor: Nanostics
Summary
This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater or equal to 3 ng/mL.
Official title: Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
Key Details
Gender
MALE
Age Range
40 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
2800
Start Date
2019-06-06
Completion Date
2027-03
Last Updated
2025-05-30
Healthy Volunteers
No
Conditions
Interventions
Blood test: ClarityDX Prostate
PSA on patients who are suspected to have prostate cancer and will undergo a prostate biopsy. ClarityDX Prostate Risk Score will be compared with biopsy results to assess its predictive accuracy.
Locations (3)
Johns Hopkins University
Baltimore, Maryland, United States
Prostate Cancer Centre
Calgary, Alberta, Canada
Kipnes Urology Centre
Edmonton, Alberta, Canada