Assessing the ClarityDX Prostate tool for prostate cancer risk evaluation
Establishing the Clinical Utility of ClarityDX Prostate
This study is testing a new tool to help doctors and men understand their risk of serious prostate cancer so they can make better decisions about whether they need further tests or procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1074 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Nanostics Industry-sponsored |
| Locations | 2 sites (Calgary, Alberta and 1 other locations) |
| Trial ID | NCT06678828 on ClinicalTrials.gov |
What this trial studies
This study evaluates the ClarityDX Prostate tool, which combines total and free PSA levels with clinical features to assess the risk of clinically significant prostate cancer in men. By utilizing a decision support model, the study aims to help clinicians and patients make informed decisions regarding the need for imaging or biopsy procedures. The approach aligns with guidelines from the Canadian Urological Association to optimize patient management and reduce unnecessary healthcare utilization. The study will be conducted in real-world settings at specific urology clinics in Alberta, Canada.
Who should consider this trial
Good fit: Ideal candidates are males aged 18 and older who have been referred to urology with suspicion of prostate cancer and have no prior prostate cancer diagnosis.
Not a fit: Patients who are unwilling to participate in the study or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly improve the accuracy of prostate cancer risk assessment, leading to better-targeted biopsies and imaging.
How similar studies have performed: Other studies have shown promise in using decision support models for prostate cancer risk assessment, indicating that this approach is both relevant and potentially effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males ≥ 18 years of age 2. Referred to urology for suspicion of prostate cancer 3. No prior prostate cancer diagnosis 4. Willing to participate in the study 5. Availability for cancer care in the jurisdiction of recruitment Exclusion Criteria: 1. Unwilling to participate in the study 2. Unable to consent
Where this trial is running
Calgary, Alberta and 1 other locations
- Prostate Cancer Centre — Calgary, Alberta, Canada (Recruiting)
- Kipnes Urology Centre — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Adam Kinnaird, MD PhD FRCSC — University of Alberta
- Study coordinator: Catalina Vasquez, MSc. C.Mgr.
- Email: info@nanosticsdx.com
- Phone: 800-672-2027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.