NCT03957252Active, not recruiting
Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2800 (estimated)
- First submitted
- 17 May 2019
- Start date
- 6 Jun 2019
- Primary completion date
- Mar 2027
- Lead sponsor
- Nanostics
- Diseases
- Prostate cancer
- NCT number
- NCT03957252
What you commit to
- Study type: Observational
- Planned participants: 2800
- From 6 Jun 2019 to the primary completion date, Mar 2027
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
Age
- Under the age of 40 years of age or over the age of 75 years of age.
Other
- Unwilling to participate in the study;
- Unavailable for biopsy procedure in recruitment areas;
- Not undergoing a prostate biopsy;
Who the study is looking for
- Males between 40-75 (inclusive) years of age;
- With and without family history of prostate cancer;
- No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
- Total PSA results \>/= 3ng/mL collected within 6m of enrollment;
- Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta or other based on recruitment jurisdiction) to disclose health-related information to study;
- Undergoing a diagnostic prostate biopsy; and
- Provided informed consent to participate in the study.
Age in the registry: 40 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prostate Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Kipnes Urology Centre Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.