Status:
TERMINATED
Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy
Lead Sponsor:
ATGen Canada Inc
Conditions:
Immunity, Innate
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
NA
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 usin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03242265
Start Date
April 4 2017
End Date
March 20 2019
Last Update
July 5 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Princess Margaret Cancer Center, University Health Network
Toronto, Ontario, Canada, M5G 1Z5