Clinical trial NCT03957252: Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer
Official title: Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Prostate Cancer
Keywords: ClarityDX Prostate
Diagnosis
Reflex Test
Lead sponsor: Nanostics
Sponsor class: INDUSTRY
Collaborators: name: Alberta Prostate Cancer Research Initiative, APCaRI
name: Prostate Cencer Centre, Calgary
name: Alberta Cancer Foundation
name: Alberta Innovates Health Solutions
name: Motorcycle Ride for Dad
name: University Hospital Foundation - The Kaye Fund Competition
name: Alberta Precision Laboratories
name: Kipnes Urology Centre
First posted: 2019-05-21
Enrollment: 2800
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective training and validation cohort study 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. Only patients with Total PSA \>/= 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test.

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.

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.

This prospective training and validation cohort study 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy
timeFrame: 3 years
measure: Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance
timeFrame: 4 years
measure: MRI: prediction of PI-RADS pre-diagnostic biopsy
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Calgary
country: Canada
facility: Prostate Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Kipnes Urology Centre
state: Alberta
Study officials:
affiliation: Kipnes Urology Centre, University of Alberta
name: Adrian S Fairey, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Alberta Institute of Urology, University of Calgary
name: Matthew E Hyndman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hyndman ME, Paproski RJ, Kinnaird A, Fairey A, Marks L, Pavlovich CP, Fletcher SA, Zachoval R, Adamcova V, Stejskal J, Aprikian A, Wallis CJD, Pink D, Vasquez C, Beatty PH, Lewis JD. Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform. NPJ Digit Med. 2024 Jun 20;7(1):163. doi: 10.1038/s41746-024-01167-9.