APCaRI-05: Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
Study Details
Study Description
Brief Summary
This study is designed to determine the accuracy of blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater or equal to 3 ng/mL.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 in total, 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Training Cohort 1400 men, 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 PSA greater than or equal to than 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test at DynaLIFE Medical Labs in Edmonton, Alberta. |
Diagnostic Test: Blood test: ClarityDX Prostate
Extracellular Vesicle profiling 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, 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 PSA greater than or equal to 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test at DynaLIFE Medical Labs in Edmonton, Alberta. |
Diagnostic Test: Blood test: ClarityDX Prostate
Extracellular Vesicle profiling 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.
|
Outcome Measures
Primary Outcome Measures
- Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy [3 years]
For the first 1,400 patients, processed microflow cytometry data for each patient will be linked with patient clinical data to determine which patients have benign vs. aggressive prostate cancer. 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males between 40-75 years of age;
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With and without family history of prostate cancer;
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No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
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PSA (Roche Cobas) results >/= 3ng/mL and collected within 6m of enrollment;
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Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta) to disclose health-related information to study;
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Undergoing a diagnostic prostate biopsy; and
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Provided informed consent to participate in the study.
Exclusion Criteria:
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Unwilling to participate in the study;
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Unavailable for biopsy procedure in recruitment areas;
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Not undergoing a prostate biopsy;
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Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
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Under the age of 40 years of age or over the age of 75 years of age.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Century Clinical Research Institute | Daytona Beach | Florida | United States | 32117 |
| 2 | Johns Hopkins University | Baltimore | Maryland | United States | 21218 |
| 3 | Prostate Cancer Centre | Calgary | Alberta | Canada | T2V 1P9 |
| 4 | Kipnes Urology Centre | Edmonton | Alberta | Canada | T6G 1Z1 |
Sponsors and Collaborators
- Nanostics
- Alberta Prostate Cancer Research Initiative, APCaRI
- DynaLIFE Medical Laboratories
- Prostate Cencer Centre, Calgary
- Northern Alberta Urology Centre
- Alberta Cancer Foundation
- Alberta Innovates Health Solutions
- Motorcycle Ride for Dad
- University Hospital Foundation - The Kaye Fund Competition
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 Documents (Full-Text)
More Information
Publications
None provided.- APCaRI-05