Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer (APCaRI-05)

• ClinicalTrials.gov Identifier: NCT03957252
• Recruitment Status: Recruiting
• First Posted: May 21, 2019
• Last Update Posted: April 13, 2022
• Sponsor: Nanostics
• Collaborators: Alberta Prostate Cancer Research Initiative, APCaRI; DynaLIFE Medical Laboratories; Prostate Cencer Centre, Calgary; Northern Alberta Urology Centre; Alberta Cancer Foundation; Alberta Innovates Health Solutions; Motorcycle Ride for Dad; University Hospital Foundation - The Kaye Fund Competition
• Information provided by (Responsible Party): Nanostics

Study Description

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.

Condition or disease	Intervention/treatment
Prostate Cancer	Diagnostic Test: Blood test: ClarityDX Prostate

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.

This prospective training and validation cohort study will consist of up to 2,800 consenting men in total, 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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 2800 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: June 6, 2019
• Estimated Primary Completion Date: October 2023
• Estimated Study Completion Date: December 2023

Groups and Cohorts

Group/Cohort	Intervention/treatment
Training Cohort; 1400 men, 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 PSA greater than or equal to than 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test at DynaLIFE Medical Labs in Edmonton, Alberta.	Diagnostic Test: Blood test: ClarityDX Prostate; Extracellular Vesicle profiling 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, 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 PSA greater than or equal to 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test at DynaLIFE Medical Labs in Edmonton, Alberta.	Diagnostic Test: Blood test: ClarityDX Prostate; Extracellular Vesicle profiling 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.

Outcome Measures

Primary Outcome Measures :

1. Diagnostic Clinical Performance: prediction of clinically significant prostate cancer at biopsy [ Time Frame: 3 years ]

   For the first 1,400 patients, processed microflow cytometry data for each patient will be linked with patient clinical data to determine which patients have benign vs. aggressive prostate cancer.

   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.

Biospecimen Retention:   Samples Without DNA

Serum Separator Tube (SST) Serum

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

This prospective training and validation cohort study will consist of up to 2,800 consenting men in total (1,400 in the training cohort and up to 1,400 in the validation cohort), 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. Only patients with PSA (Roche Cobas) >/= 3 ng/mL will be selected to have the ClarityDX Prostate test performed as a reflex test at DynaLIFE.

Criteria

Inclusion Criteria:

1. Males between 40-75 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. PSA (Roche Cobas) results >/= 3ng/mL and 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.

Contacts and Locations

Contacts

Contact: Catalina Vasquez, MSc; 1780-499-5396; catalina.vasquez@nanosticsdx.com

Contact: Sandra Idaminabo, MD; +1 587-568-5139; sandra.idaminabo@nanosticsdx.com

Locations

United States, Florida

Century Clinical Research Institute; Active, not recruiting

Daytona Beach, Florida, United States, 32117

United States, Maryland

Johns Hopkins University; Recruiting

Baltimore, Maryland, United States, 21218

Contact: Christian Pavlovich, MD

Principal Investigator: Christian Pavlovich, MD

Canada, Alberta

Prostate Cancer Centre; Recruiting

Calgary, Alberta, Canada, T2V 1P9

Contact: Megan Balakas, RN, BSN, BS 1403-943-8953 megan.b@prostatecancercentre.ca

Principal Investigator: Matthew E Hyndman, MD, PhD

Kipnes Urology Centre; Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Contact: Anais Martin, PhD 780-407-5668 amedinam@ualberta.ca

Principal Investigator: Adrian S Fairey, MD, MSC

Sponsors and Collaborators

Nanostics

Alberta Prostate Cancer Research Initiative, APCaRI

DynaLIFE Medical Laboratories

Prostate Cencer Centre, Calgary

Northern Alberta Urology Centre

Alberta Cancer Foundation

Alberta Innovates Health Solutions

Motorcycle Ride for Dad

University Hospital Foundation - The Kaye Fund Competition

Investigators

• Principal Investigator: Adrian S Fairey, MD, MSc; Northern Alberta Urology Centre, University of Alberta
• Principal Investigator: Matthew E Hyndman, MD, PhD; Southern Alberta Institute of Urology, University of Calgary

  Study Documents (Full-Text)

Documents provided by Nanostics:

Study Protocol and Statistical Analysis Plan  [PDF] April 10, 2019

More Information

• Responsible Party: Nanostics
• ClinicalTrials.gov Identifier: NCT03957252
• Other Study ID Numbers: APCaRI-05
• First Posted: May 21, 2019
• Last Update Posted: April 13, 2022
• Last Verified: April 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanostics:

ClarityDX Prostate; Diagnosis; Reflex Test; Extracellular Vesicle

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases