Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1074 participants
INTERVENTIONAL
2025-04-14
2028-12-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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The control
Control/Standard of Care arm- ClarityDX Prostate will be run for these participants. Participants and healthcare providers will be blinded to the results report and participants will be considered for prostate MRI/advanced imaging and /or biopsy based on standard clinical criteria. The results of the ClarityDX Prostate will be unblinded to the study teams at the 12 months follow-up visit. The study team will then share the test results with the participant's health care team to assess whether there is a need to change the participant's care path.
ClarityDX Prostate, blinded
ClarityDX Prostate will be run for the control participants. Participants (and healthcare team) in the control arm will be blinded to the ClarityDX Prostate results and will be considered for prostate MRI/advanced imaging and/or biopsy based on standard of care criteria. The result of the ClarityDX Prostate will be unblinded to study teams at the 12 months follow-up visit (± 2 months). The study team will then share the test results with the participant's health care team to assess whether there is a need to change the participant's care path.
ClarityDX Prostate
The report will be shared with the healthcare team of participants randomized into the ClarityDX Prostate arm before the healthcare team decides whether to perform an MRI/advanced imaging and/or biopsy.
ClarityDX Prostate
The ClarityDX Prostate report will be shared with the healthcare team of participants randomized into ClarityDX Prostate arm before the healthcare team decides whether to perform an MRI/advanced imaging and/or biopsy.
Interventions
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ClarityDX Prostate
The ClarityDX Prostate report will be shared with the healthcare team of participants randomized into ClarityDX Prostate arm before the healthcare team decides whether to perform an MRI/advanced imaging and/or biopsy.
ClarityDX Prostate, blinded
ClarityDX Prostate will be run for the control participants. Participants (and healthcare team) in the control arm will be blinded to the ClarityDX Prostate results and will be considered for prostate MRI/advanced imaging and/or biopsy based on standard of care criteria. The result of the ClarityDX Prostate will be unblinded to study teams at the 12 months follow-up visit (± 2 months). The study team will then share the test results with the participant's health care team to assess whether there is a need to change the participant's care path.
Eligibility Criteria
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Inclusion Criteria
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
2. Unable to consent
18 Years
MALE
No
Sponsors
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Nanostics
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Kinnaird, MD PhD FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
M Eric Hyndman, MD, PhD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Prostate Cancer Centre
Calgary, Alberta, Canada
Kipnes Urology Centre
Edmonton, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Viana Dayhimi
Role: backup
References
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Hyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9.
Related Links
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Related Info
Related Info
Other Identifiers
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APCaRI-08
Identifier Type: -
Identifier Source: org_study_id
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