- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957252
Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer (APCaRI-05)
Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The main objective of this study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically-significant prostate cancer in a prospective cohort of men to be recruited in North America when they are scheduled for a biopsy as a result of on an elevated PSA.
This prospective training and validation cohort study will consist of up to 2,800 consenting men from Alberta in addition to up to 2,500 men from external institutions, between ages 40-75 years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Catalina Vasquez, MSc
- Phone Number: 1780-499-5396
- Email: catalina.vasquez@nanosticsdx.com
Study Contact Backup
- Name: Sandra Idaminabo, MD
- Phone Number: +1 587-568-5139
- Email: sandra.idaminabo@nanosticsdx.com
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2V 1P9
- Prostate Cancer Centre
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Edmonton, Alberta, Canada, T6G 1Z1
- Kipnes Urology Centre
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Maryland
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Baltimore, Maryland, United States, 21218
- Johns Hopkins University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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) to disclose health-related information to study;
- Undergoing a diagnostic prostate biopsy; and
- Provided informed consent to participate in the study.
Exclusion Criteria:
- Unwilling to participate in the study;
- Unavailable for biopsy procedure in recruitment areas;
- Not undergoing a prostate biopsy;
- Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
- Under the age of 40 years of age or over the age of 75 years of age.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Training Cohort
Up to 1400 men from Alberta in addition to up to 2,500 men from external institutions, 40-75 years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
Only patients with Total PSA greater than or equal to than 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test.
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PSA on patients who are suspected to have prostate cancer and will undergo a prostate biopsy.
ClarityDX Prostate Risk Score will be compared with biopsy results to assess its predictive accuracy.
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Validation Cohort
Up to 1400 men from Alberta in addition to up to 2,500 men from external institutions, 40-75 years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
Only patients with Tota PSA greater than or equal to 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test.
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PSA on patients who are suspected to have prostate cancer and will undergo a prostate biopsy.
ClarityDX Prostate Risk Score will be compared with biopsy results to assess its predictive accuracy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy
Time Frame: 3 years
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Training Phase: Processed clinical features of each patient will be analyzed using machine learning to predict clinically significant prostate cancer, with the output being the ClarityDX Prostate Risk Score. Validation Phase: The models created during the Training Phase will be locked down and then used to determine the probability of approximately 1,400 patients in the investigational Validation Phase having clinically significant prostate cancer. |
3 years
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Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance
Time Frame: 2 years
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2 years
|
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MRI: prediction of PI-RADS pre-diagnostic biopsy
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Adrian S Fairey, MD, MSc, Northern Alberta Urology Centre, University of Alberta
- Principal Investigator: Matthew E Hyndman, MD, PhD, Southern Alberta Institute of Urology, University of Calgary
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- APCaRI-05
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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