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

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ClinicalTrials.gov Identifier: NCT03957252
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : June 18, 2021
Sponsor:
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

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 than 3 and no higher than 10 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 Alberta, Whitehorse and in the United States of 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.

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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 : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 3 ng/mL and no greater than 10ng/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 3 ng/mL and no greater than 10ng/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.




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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) greater than 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 > than 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957252


Contacts
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Contact: Catalina Vasquez, MSc 1780-499-5396 catalina.vasquez@nanosticsdx.com
Contact: Aditya Muley, MSc +1 647-539-1845 aditya.muley@nanosticsdx.com

Locations
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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         
Northern Alberta 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         
Canada, Yukon Territory
Yukon Not yet recruiting
Whitehorse, Yukon Territory, Canada
Contact: Sean Secord, MSc, RN       sean.secord@gmail.com   
Principal Investigator: Russell Bamford, B.A, M.B         
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
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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:
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Responsible Party: Nanostics
ClinicalTrials.gov Identifier: NCT03957252    
Other Study ID Numbers: APCaRI-05
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021

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