Subtraction Normalized Expression of Phagocytes Blood Test
Subtraction Normalized Expression of Phagocytes Blood Test: Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness
Study summary
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Eligibility
Sex
MALE
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria
* Men between 40-80 of age with at least a 10-year life expectancy
* All active surveillance protocols are accepted
* No PSA limits
Category 1:
* Patient is currently on active surveillance with only ONE previous low grade prostate biopsy.
* Patient must already be scheduled for their 1st annual biopsy under their active surveillance protocol within 90 days of enrollment date.
Category 2:
• Patient is recently diagnosed with low grade prostate cancer but has decided against active surveillance and is scheduled for radical prostatectomy within 90 days of enrollment date.
Exclusion Criteria:
Men on watchful waiting i.e. those with less than 10-year life expectancy with no intent for curative therapy
* Men with symptoms or rising PSA who have not been proven to have cancer by tissue biopsy i.e. men with only negative prostate biopsies.
* Patients with a history of a different cancer (except basal cell carcinoma)
Primary outcome measure(s)
Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population. — 1 year Collect information from repeat biopsy including any increase in gleason grade, increase in number of cores positive, and increase in % cross sectional surface area involved by tumor from the repeat biopsy.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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