Performance Assessment of Novel Test, Prostate Cancer, Prostate Cancer Screening
Conditions
Keywords
ClarityDX Prostate, Diagnosis, Reflex Test
Brief summary
This ambispective observational cohort study will evaluate the clinical performance of the ClarityDX Prostate blood test in men with a prostate-specific antigen (PSA) level of 3 ng/mL or higher who are undergoing prostate biopsy due to suspicion of prostate cancer. The study will compare ClarityDX Prostate test results with biopsy outcomes to determine the test's ability to identify the presence of clinically significant prostate cancer.
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 or other suspicion of prostate cancer and in retrospective databases from selected sites in the United States of America and the world. The training and validation analysis sets will consist of up to 2,800 consenting men from Alberta in addition to up to 5,000 men from external institutions, between ages 40-75 (inclusive) years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.
Interventions
None listed
Sponsors
Nanostics
Alberta Prostate Cancer Research Initiative, APCaRI
Prostate Cencer Centre, Calgary
Alberta Cancer Foundation
Alberta Innovates Health Solutions
Motorcycle Ride for Dad
University Hospital Foundation - The Kaye Fund Competition
Alberta Precision Laboratories
Kipnes Urology Centre
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Males between 40-75 (inclusive) years of age; 2. With and without family history of prostate cancer; 3. No prior prostate cancer diagnosis and who are referred to have a prostate biopsy; 4. Total PSA results \>/= 3ng/mL collected within 6m of enrollment; 5. Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta or other based on recruitment jurisdiction) to disclose health-related information to study; 6. Undergoing a diagnostic prostate biopsy; and 7. Provided informed consent to participate in the study.
Exclusion criteria
1. Unwilling to participate in the study; 2. Unavailable for biopsy procedure in recruitment areas; 3. Not undergoing a prostate biopsy; 4. Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or 5. Under the age of 40 years of age or over the age of 75 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy | 3 years | 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. |
| Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance | 4 years | — |
| MRI: prediction of PI-RADS pre-diagnostic biopsy | 4 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health economics | 3 years | Perform health economics and cost-benefit analyss of the test |
| Medication and co-morbidities | Baseline | Effect of selected medications and co-morbidities on the predictive value of the test |
| Analytical validity of the ClarityDX Prostate test | 1 year post enrollment | Method assessment and analytical validity of the ClarityDX Prostate test. |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORAdrian S Fairey, MD, MSc
Kipnes Urology Centre, University of Alberta
PRINCIPAL_INVESTIGATORMatthew E Hyndman, MD, PhD
Southern Alberta Institute of Urology, University of Calgary
Outcome results
None listed