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

NCT03957252 | Active Not Recruiting DMC

• 1 other identifier: APCaRI-05
• Study Type: observational
• Target: 2,800
• Locations: 2 countries
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

ClarityDX Prostate; Diagnosis; Reflex Test

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Training Cohort

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

Validation Cohort

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

Interventions

Blood test: ClarityDX Prostate DIAGNOSTIC_TEST

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.

Training Cohort; Validation Cohort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 or other based on recruitment jurisdiction) to disclose health-related information to study;
• Undergoing a diagnostic prostate biopsy; and
• Provided informed consent to participate in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanostics: lead
• Alberta Prostate Cancer Research Initiative, APCaRI: collaborator
• Prostate Cencer Centre, Calgary: collaborator
• Alberta Cancer Foundation: collaborator
• Alberta Innovates Health Solutions: collaborator
• Motorcycle Ride for Dad: collaborator
• University Hospital Foundation - The Kaye Fund Competition: collaborator
• Alberta Precision Laboratories: collaborator
• Kipnes Urology Centre: collaborator

Study Sites (3)

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Prostate Cancer Centre

Calgary, Alberta, T2V 1P9, Canada

Location

Kipnes Urology Centre

Edmonton, Alberta, T6G 1Z1, Canada

Location

Related Publications (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.

  PMID: 38902526 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Separator Tube (SST) Serum Plasma (EDTA)

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adrian S Fairey, MD, MSc

  Kipnes Urology Centre, University of Alberta

  PRINCIPAL INVESTIGATOR

• Matthew E Hyndman, MD, PhD

  Southern Alberta Institute of Urology, University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 21, 2019
• Study Start: June 6, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

US (1); CA (2)