APCaRI-05
Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer
Sponsor study identifier
observational
2,800
2 countries
3
Study Start
June 6, 2019
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 17, 2019
Actual (reported)May 21, 2019
Actual (reported)June 6, 2019
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
4 years
MRI: prediction of PI-RADS pre-diagnostic biopsy
4 years
Health economics
3 years
Medication and co-morbidities
Baseline
Analytical validity of the ClarityDX Prostate test
1 year post enrollment
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.
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9, Canada
Kipnes Urology Centre
Edmonton, Alberta, T6G 1Z1, Canada
Paproski RJ, Kinnaird A, Hyndman ME, 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. Predicting clinically significant prostate cancer with or without digital rectal exam and MRI data using ClarityDX Prostate models. NPJ Digit Med. 2026 Apr 17;9(1):467. doi: 10.1038/s41746-026-02642-1.
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.
Serum Separator Tube (SST) Serum Plasma (EDTA)
Adrian S Fairey, MD, MSc
Kipnes Urology Centre, University of Alberta
Matthew E Hyndman, MD, PhD
Southern Alberta Institute of Urology, University of Calgary
First Submitted
May 17, 2019
First Posted
May 21, 2019
Study Start
June 6, 2019
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients With Intermediate Risk Localized Prostate Cancer
Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate.
Contact the study team to confirm eligibility.
Study Completion
June 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 24, 2026
Record last verified: 2026-07
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