Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy (ANKA-PCA)

July 2, 2019 updated by: ATGen Canada Inc

Open Label, Prospective, Cross-Sectional Clinical Performance Study of the in Vitro Diagnostic Device NK VueTM: Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

This study will look at measuring the activity of natural killer (NK) cells using the in vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate biopsy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The NK Vue diagnostic test for natural killer cell activity uses the principle of stimulation of whole blood with a proprietary cytokine followed by the quantitative detection of interferon-gamma using an immunoassay. NK Vue is intended to be used for the monitoring of the immune status of individuals. Measurement of NK cell activity could be a useful tool for assessing changes in immunosurveillance in patients with conditions or diseases where NK cell activity has been shown to be affected.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1Z5
        • Princess Margaret Cancer Center, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male aged ≥ 18 years old
  2. Able to read and sign an approved informed consent form
  3. Soon to be undergoing a needle prostate biopsy for suspected prostate cancer; patients with a history of prior biopsy are not excluded provided the biopsy was negative
  4. All prior and current recorded PSA levels are < 11 ng/mL (minimum of 2 values must be available)
  5. Digital Rectal Exam performed or scheduled to be performed prior to biopsy

Exclusion Criteria:

  1. Any other established malignancy with the exception of basal cell carcinoma
  2. At time of blood collection, an active infection (eg bacterial, viral etc.) as declared by the patient
  3. Chronic inflammatory condition requiring anti-inflammatory treatment such as rheumatoid arthritis, Crohn's or ulcerative colitis, Lupus or any connective tissue condition which, in the opinion of the investigator, might affect the immune response

  4. Presently taking any of the following classes of medications on a regular basis:

    • 5-alpha reductase inhibitors
    • Anti-inflammatories, with the exception of low dose (81 mg) acetylsalicylic acid
    • Anti-androgens
    • Testosterone replacement therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
Time Frame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Test performance of NK Vue will be assessed by logistic regression, both unadjusted and adjusted for the effects of at least PSA, age, digital rectal examination, and family history
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)
Time Frame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Test performance of NK Vue will be assessed by multinomial logistic regression, using the following known predictors of prostate cancer: age, ethnicity, PSA history, family history of prostate cancer, prostate volume, digital rectal examination findings, and number of prior biopsies.
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Test performance metrics of NK Vue and PSA (each alone)
Time Frame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
The sensitivity, specificity, positive and negative predictive values for the detection of prostate cancer, will be calculated using Receiver Operating Characteristics analysis (at a cut-off of 4 ng/mL for PSA and at a cut-off of 200 pg/mL for NK Vue). Other cut-offs may be used to perform additional statistical analyses for test performance.
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Impact of combination of NK Vue and PSA on the test performance of PSA
Time Frame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
The sensitivity, specificity, positive and negative predictive values for the detection of prostate cancer, will be calculated using Receiver Operating Characteristics analysis under combined conditions.
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ATGen Canada Inc

Investigators

  • Principal Investigator: Neil E Fleshner, MPH,MD,FRCSC, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 4, 2017

Primary Completion (ACTUAL)

March 20, 2019

Study Completion (ACTUAL)

March 20, 2019

Study Registration Dates

First Submitted

August 3, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (ACTUAL)

August 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANKA-PCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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