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

NCT ID: NCT03957252

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-06
• Study Completion Date: 2027-03-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood test: ClarityDX Prostate

Intervention Type: 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.

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.

Blood test: ClarityDX Prostate

Intervention Type: 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.

Interventions

Blood test: ClarityDX Prostate

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alberta Prostate Cancer Research Initiative, APCaRI

UNKNOWN

Sponsor Role: collaborator

Prostate Cencer Centre, Calgary

UNKNOWN

Sponsor Role: collaborator

Alberta Cancer Foundation

OTHER

Sponsor Role: collaborator

Alberta Innovates Health Solutions

OTHER

Sponsor Role: collaborator

Motorcycle Ride for Dad

UNKNOWN

Sponsor Role: collaborator

University Hospital Foundation - The Kaye Fund Competition

UNKNOWN

Sponsor Role: collaborator

Alberta Precision Laboratories

UNKNOWN

Sponsor Role: collaborator

Kipnes Urology Centre

UNKNOWN

Sponsor Role: collaborator

Nanostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrian S Fairey, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Kipnes Urology Centre, University of Alberta

Matthew E Hyndman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Southern Alberta Institute of Urology, University of Calgary

Locations

Johns Hopkins University

Baltimore, Maryland, United States

Prostate Cancer Centre

Calgary, Alberta, Canada

Kipnes Urology Centre

Edmonton, Alberta, Canada

Countries

United States; Canada

References

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.

Reference Type: RESULT

PMID: 38902526 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

APCaRI-05

Identifier Type: -

Identifier Source: org_study_id