| NCT ID | NCT06678828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanostics |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,074 participants |
| Start Date | 2025-04-14 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,074 participants in total. It began in 2025-04-14 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
ClarityDX Prostate builds upon the utility of total and free PSA as well as simple clinical features in a decision support model to determine a patient's risk of having clinically significant prostate cancer. The highly accurate ClarityDX Prostate risk score enables clinicians and patients to collectively make more informed decisions regarding the appropriateness of subsequent imaging or biopsy procedures. The clinical pathway aligns with the Canadian Urological Association (CUA) to use adjunctive strategies to better stratify risk of clinically significant prostate cancer. ClarityDX Prostate consists of four separate models that can be used depending on the information available: 1. ClarityDX Prostate. This model incorporates the patient's total PSA and free PSA levels as well as the age of the patient and whether they have had a previous negative biopsy. 2. ClarityDX Prostate + DRE. This model incorporates ClarityDX Prostate + DRE (normal or abnormal DRE findings). 3. ClarityDX Prostate + MRI. This model incorporates ClarityDX Prostate + MRI (PI-RADS score and prostate volume as determined from an mpMRI scan). 4. ClarityDX Prostate + MRI + DRE. This model incorporates ClarityDX Prostate + MRI + DRE. PRIMARY OBJECTIVE The purpose of this study is to investigate the clinical utility of ClarityDX Prostate on in reducing further healthcare utilization for men identified to be at risk of prostate cancer. SECONDARY OBJECTIVES * Assess the effect of ClarityDX Prostate on the proportion of negative biopsies and biopsies diagnosing Gleason Grade (GG)\<2. * Measure the difference in MRI numbers between the test and control groups. * Evaluate the effect of ClarityDX Prostate on the prioritization of healthcare services to participants with high-risk of having clinically significant prostate cancer. * Infer the potential to use ClarityDX Prostate for prostate cancer screening to inform urology referral. * Perform a health economics assessment and cost-benefit analysis for the use of ClarityDX Prostate. This is a prospective, randomized, two-armed clinical utility study that will enroll participants referred to urology clinics for suspicion of prostate cancer. The arms of the study are ClarityDX Prostate and Standard of Care (SOC).
Eligibility 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
Contact & Investigator
Adam Kinnaird, MD PhD FRCSC
PRINCIPAL INVESTIGATOR
University of Alberta
Frequently Asked Questions
Who can join the NCT06678828 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06678828 currently recruiting?
Yes, NCT06678828 is actively recruiting participants. Contact the research team at info@nanosticsdx.com for enrollment information.
Where is the NCT06678828 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada.
Who is sponsoring the NCT06678828 clinical trial?
NCT06678828 is sponsored by Nanostics. The principal investigator is Adam Kinnaird, MD PhD FRCSC at University of Alberta. The trial plans to enroll 1,074 participants.
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