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

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ClinicalTrials.gov Identifier: NCT03242265
Recruitment Status : Terminated (Lack of funding)
First Posted : August 8, 2017
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
ATGen Canada Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Immunity, Innate Prostatic Neoplasm Diagnostic Test: IVDD for NK cell activity in whole blood Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description: NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab
Primary Purpose: Screening
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
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : March 20, 2019
Actual Study Completion Date : March 20, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: IVDD for NK cell activity in whole blood
    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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-representation (must have a prostate gland)
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03242265


Locations
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Canada, Ontario
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario, Canada, M5G 1Z5
Sponsors and Collaborators
ATGen Canada Inc
Investigators
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Principal Investigator: Neil E Fleshner, MPH,MD,FRCSC University Health Network, Toronto

Publications:
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Responsible Party: ATGen Canada Inc
ClinicalTrials.gov Identifier: NCT03242265     History of Changes
Other Study ID Numbers: ANKA-PCA
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases