Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Blood test: ClarityDX Prostate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Training Cohort<br>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. | Diagnostic Test: Blood test: ClarityDX Prostate<br>* 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.<br>|
| Validation Cohort<br>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. | Diagnostic Test: Blood test: ClarityDX Prostate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance |  | 2 years | 
| MRI: prediction of PI-RADS pre-diagnostic biopsy |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ClarityDX Prostate, Diagnosis, Reflex Test