Back to resultsMeasurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy (ANKA-PCA)
Primary Purpose
Immunity, Innate, Prostatic Neoplasm
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
IVDD for NK cell activity in whole blood
Sponsored by
About this trial
This is an interventional screening trial for Immunity, Innate
Eligibility Criteria
Inclusion Criteria:
- Male aged ≥ 18 years old
- Able to read and sign an approved informed consent form
- 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
- All prior and current recorded PSA levels are < 11 ng/mL (minimum of 2 values must be available)
- Digital Rectal Exam performed or scheduled to be performed prior to biopsy
Exclusion Criteria:
- Any other established malignancy with the exception of basal cell carcinoma
- At time of blood collection, an active infection (eg bacterial, viral etc.) as declared by the patient
- 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
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
Sites / Locations
- Princess Margaret Cancer Center, University Health Network
Outcomes
Primary Outcome Measures
The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
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
The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)
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.
Test performance metrics of NK Vue and PSA (each alone)
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.
Impact of combination of NK Vue and PSA on the test performance of PSA
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03242265
Brief Title
Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy
Acronym
ANKA-PCA
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
March 20, 2019 (Actual)
Study Completion Date
March 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ATGen Canada Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immunity, Innate, Prostatic Neoplasm
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Masking Description
NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab
Allocation
N/A
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
IVDD for NK cell activity in whole blood
Other Intervention Name(s)
NK Vue
Intervention 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.
Primary Outcome Measure Information:
Title
The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
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
Time Frame
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Secondary Outcome Measure Information:
Title
The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)
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.
Time Frame
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Title
Test performance metrics of NK Vue and PSA (each alone)
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.
Time Frame
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Title
Impact of combination of NK Vue and PSA on the test performance of PSA
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.
Time Frame
NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-representation (must have a prostate gland)
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male aged ≥ 18 years old
Able to read and sign an approved informed consent form
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
All prior and current recorded PSA levels are < 11 ng/mL (minimum of 2 values must be available)
Digital Rectal Exam performed or scheduled to be performed prior to biopsy
Exclusion Criteria:
Any other established malignancy with the exception of basal cell carcinoma
At time of blood collection, an active infection (eg bacterial, viral etc.) as declared by the patient
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil E Fleshner, MPH,MD,FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Center, University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28436356
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.
Results Reference
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PubMed Identifier
24223759
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.
Results Reference
background
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Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy
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