<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03242265</url>
  </required_header>
  <id_info>
    <org_study_id>ANKA-PCA</org_study_id>
    <nct_id>NCT03242265</nct_id>
  </id_info>
  <brief_title>Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy</brief_title>
  <acronym>ANKA-PCA</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ATGen Canada Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ATGen Canada Inc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will look at measuring the activity of natural killer (NK) cells using the in&#xD;
      vitro diagnostic device NK Vue in subjects being screened for prostate cancer using prostate&#xD;
      biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The NK Vue diagnostic test for natural killer cell activity uses the principle of stimulation&#xD;
      of whole blood with a proprietary cytokine followed by the quantitative detection of&#xD;
      interferon-gamma using an immunoassay. NK Vue is intended to be used for the monitoring of&#xD;
      the immune status of individuals. Measurement of NK cell activity could be a useful tool for&#xD;
      assessing changes in immunosurveillance in patients with conditions or diseases where NK cell&#xD;
      activity has been shown to be affected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding&#xD;
  </why_stopped>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy</measure>
    <time_frame>NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)</measure>
    <time_frame>NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test performance metrics of NK Vue and PSA (each alone)</measure>
    <time_frame>NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of combination of NK Vue and PSA on the test performance of PSA</measure>
    <time_frame>NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <enrollment type="Actual">84</enrollment>
  <condition>Immunity, Innate</condition>
  <condition>Prostatic Neoplasm</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>IVDD for NK cell activity in whole blood</intervention_name>
    <description>Two samples of one mL of blood (for baseline IFN-gamma activity and for NK cell activity) and blood samples collected for C-Reactive Protein and White Blood Cell Count, taken up to 8 weeks prior to biopsy and before treatment with antibiotics.</description>
    <other_name>NK Vue</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male aged ≥ 18 years old&#xD;
&#xD;
          2. Able to read and sign an approved informed consent form&#xD;
&#xD;
          3. Soon to be undergoing a needle prostate biopsy for suspected prostate cancer; patients&#xD;
             with a history of prior biopsy are not excluded provided the biopsy was negative&#xD;
&#xD;
          4. All prior and current recorded PSA levels are &lt; 11 ng/mL (minimum of 2 values must be&#xD;
             available)&#xD;
&#xD;
          5. Digital Rectal Exam performed or scheduled to be performed prior to biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any other established malignancy with the exception of basal cell carcinoma&#xD;
&#xD;
          2. At time of blood collection, an active infection (eg bacterial, viral etc.) as&#xD;
             declared by the patient&#xD;
&#xD;
          3. Chronic inflammatory condition requiring anti-inflammatory treatment such as&#xD;
             rheumatoid arthritis, Crohn's or ulcerative colitis, Lupus or any connective tissue&#xD;
             condition which, in the opinion of the investigator, might affect the immune response&#xD;
&#xD;
          4. Presently taking any of the following classes of medications on a regular basis:&#xD;
&#xD;
               -  5-alpha reductase inhibitors&#xD;
&#xD;
               -  Anti-inflammatories, with the exception of low dose (81 mg) acetylsalicylic acid&#xD;
&#xD;
               -  Anti-androgens&#xD;
&#xD;
               -  Testosterone replacement therapy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-representation (must have a prostate gland)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil E Fleshner, MPH,MD,FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Center, University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Barkin J, Rodriguez-Suarez R, Betito K. Association between natural killer cell activity and prostate cancer: a pilot study. Can J Urol. 2017 Apr;24(2):8708-8713.</citation>
    <PMID>28436356</PMID>
  </reference>
  <reference>
    <citation>Koo KC, Shim DH, Yang CM, Lee SB, Kim SM, Shin TY, Kim KH, Yoon HG, Rha KH, Lee JM, Hong SJ. Reduction of the CD16(-)CD56bright NK cell subset precedes NK cell dysfunction in prostate cancer. PLoS One. 2013 Nov 4;8(11):e78049. doi: 10.1371/journal.pone.0078049. eCollection 2013.</citation>
    <PMID>24223759</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242265
org study id: ANKA-PCA
nct id: NCT03242265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: Single (Outcomes Assessor)
masking description: NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab
measure: 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
description: 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
measure: 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
description: 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.
measure: 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
description: 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.
measure: 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
description: 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.
intervention type: Diagnostic Test
intervention name: IVDD for NK cell activity in whole blood
description: Two samples of one mL of blood (for baseline IFN-gamma activity and for NK cell activity) and blood samples collected for C-Reactive Protein and White Blood Cell Count, taken up to 8 weeks prior to biopsy and before treatment with antibiotics.
other name: NK Vue
criteria: 
gender: Male
gender based: Yes
gender description: Self-representation (must have a prostate gland)
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neil E Fleshner, MPH,MD,FRCSC
role: Principal Investigator
affiliation: University Health Network, Toronto
facility: 
country: Canada
citation: Barkin J, Rodriguez-Suarez R, Betito K. Association between natural killer cell activity and prostate cancer: a pilot study. Can J Urol. 2017 Apr;24(2):8708-8713.
PMID: 28436356
citation: Koo KC, Shim DH, Yang CM, Lee SB, Kim SM, Shin TY, Kim KH, Yoon HG, Rha KH, Lee JM, Hong SJ. Reduction of the CD16(-)CD56bright NK cell subset precedes NK cell dysfunction in prostate cancer. PLoS One. 2013 Nov 4;8(11):e78049. doi: 10.1371/journal.pone.0078049. eCollection 2013.
PMID: 24223759
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No