Clinical trial NCT03242265: Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy
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
Overall status: TERMINATED
Phase: NA
Conditions: Immunity, Innate
Prostatic Neoplasm
Lead sponsor: ATGen Canada Inc
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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

Primary outcomes:
measure: The ability of NK cell activity to predict prostate cancer (yes/no) on biopsy
timeFrame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Secondary outcomes:
measure: The ability of NK cell activity to predict tumor grade (Gleason 2-6 vs. no cancer; Gleason 7-10 vs. no cancer)
timeFrame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
measure: Test performance metrics of NK Vue and PSA (each alone)
timeFrame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
measure: Impact of combination of NK Vue and PSA on the test performance of PSA
timeFrame: NK cell activity is measured up to 8 weeks prior to biopsy and prior to starting any antibiotic treatment
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Center, University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Neil E Fleshner, MPH,MD,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.