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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVDD for NK cell activity in whole blood | Diagnostic Test | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment |
| 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) | 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 |
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Inclusion Criteria:
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:
Self-representation (must have a prostate gland)
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| Name | Affiliation | Role |
|---|---|---|
| Neil E Fleshner, MPH,MD,FRCSC | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Center, University Health Network | Toronto | Ontario | M5G 1Z5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28436356 | Background | 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. | |
| 24223759 | Background | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab
| 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. | 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 | 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |