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Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

NCT03957252 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2800

Last updated 2026-07-24

No results posted yet for this study

Summary

This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. The study will compare ClarityDX Prostate test results with biopsy outcomes to determine the test's ability to identify the presence of clinically significant prostate cancer.

Conditions

  • Prostate Cancer
  • Prostate Cancer Screening
  • Performance Assessment of Novel Test

Sponsors & Collaborators

  • Alberta Prostate Cancer Research Initiative, APCaRI

    collaborator UNKNOWN

  • Prostate Cencer Centre, Calgary

    collaborator UNKNOWN

  • Alberta Cancer Foundation

    collaborator OTHER

  • Alberta Innovates Health Solutions

    collaborator OTHER

  • Motorcycle Ride for Dad

    collaborator UNKNOWN

  • University Hospital Foundation - The Kaye Fund Competition

    collaborator UNKNOWN

  • Alberta Precision Laboratories

    collaborator UNKNOWN

  • Kipnes Urology Centre

    collaborator UNKNOWN

  • Nanostics

    lead INDUSTRY

Principal Investigators

  • Adrian S Fairey, MD, MSc · Kipnes Urology Centre, University of Alberta

  • Matthew E Hyndman, MD, PhD · Southern Alberta Institute of Urology, University of Calgary

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2027-03-31
Completion
2027-06-30

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03957252 on ClinicalTrials.gov