Prostate Cancer Clinical Trial
— APCaRI-05Official title:
Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
Verified date | December 2023 |
Source | Nanostics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 2800 |
Est. completion date | December 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 75 Years |
Eligibility | 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) 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Prostate Cancer Centre | Calgary | Alberta |
Canada | Kipnes Urology Centre | Edmonton | Alberta |
United States | Johns Hopkins University | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Nanostics | Alberta Cancer Foundation, Alberta Innovates Health Solutions, Alberta Prostate Cancer Research Initiative, APCaRI, DynaLIFE Medical Laboratories, Motorcycle Ride for Dad, Northern Alberta Urology Centre, Prostate Cencer Centre, Calgary, University Hospital Foundation - The Kaye Fund Competition |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy | 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 | |
Primary | Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance | 2 years | ||
Primary | MRI: prediction of PI-RADS pre-diagnostic biopsy | 2 years |
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