NCT03242265

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

August 3, 2017

Last Update Submit

July 2, 2019

Conditions

Immunity, InnateProstatic Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 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

  • 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

Interventions

IVDD for NK cell activity in whole bloodDIAGNOSTIC_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.

Also known as: NK Vue

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsSelf-representation (must have a prostate gland)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • alpha reductase inhibitors
  • Anti-inflammatories, with the exception of low dose (81 mg) acetylsalicylic acid
  • Anti-androgens
  • Testosterone replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Center, University Health Network

Toronto, Ontario, M5G 1Z5, Canada

Location

Related 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.

    PMID: 28436356BACKGROUND

  • 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.

    PMID: 24223759BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Neil E Fleshner, MPH,MD,FRCSC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
NK cell activity not provided to investigator prior to biopsy; results of biopsy not provided to biochemistry lab
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

April 4, 2017

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)