Clinical trial · Interventional
Measurement of Natural Killer Cell Activity in Whole Blood in Men Being Screened for Prostate Cancer With Biopsy
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
NCT03242265CI-TRIAL-00039319ANKA-PCAterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Immunity, Innate | — | UNRESOLVED | — |
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IVDD for NK cell activity in whole blood | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- 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
Secondary outcomes (3)
- 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
- description
- 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.
- measure
- Test performance metrics of NK Vue and PSA (each alone)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBarkin 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 28436356
- BACKGROUNDKoo 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 24223759