Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy

Prostatic Neoplasm Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03242265
• Other study ID #: ANKA-PCA
• Status: Terminated
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: March 20, 2019

Study information

• Verified date: July 2019
• Source: ATGen Canada Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 84
• Est. completion date: March 20, 2019
• Est. primary completion date: March 20, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunity, Innate
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Center, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
ATGen Canada Inc

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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