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

Prostate Cancer Clinical Trial

— APCaRI-05  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03957252
• Other study ID #: APCaRI-05
• Status: Active, not recruiting
• Start date: June 6, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Nanostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2800
• Est. completion date: December 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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) 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Canada	Prostate Cancer Centre	Calgary	Alberta
Canada	Kipnes Urology Centre	Edmonton	Alberta
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (9)

Lead Sponsor	Collaborator
Nanostics	Alberta Cancer Foundation, Alberta Innovates Health Solutions, Alberta Prostate Cancer Research Initiative, APCaRI, DynaLIFE Medical Laboratories, Motorcycle Ride for Dad, Northern Alberta Urology Centre, Prostate Cencer Centre, Calgary, University Hospital Foundation - The Kaye Fund Competition

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Active Surveillance: prediction of Gleason Grade Group on confirmatory/follow-up biopsies for participants on Active Surveillance		2 years
Primary	MRI: prediction of PI-RADS pre-diagnostic biopsy		2 years