Immunity, Innate, Prostatic Neoplasm
Conditions
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.
Interventions
DIAGNOSTIC_TESTIVDD 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.
Sponsors
ATGen Canada Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
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
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy | 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
| Measure | Time frame | Description |
|---|---|---|
| The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer) | 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. |
| Test performance metrics of NK Vue and PSA (each alone) | 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. |
| Impact of combination of NK Vue and PSA on the test performance of PSA | 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. |
Countries
Canada
Outcome results
None listed