Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
Recruiting · NCT04052048 · Observational (researchers observe without assigning treatment) · Lead sponsor: Immunis.AI
View the official record on ClinicalTrials.gov →Interventions studied
Subtraction Normalized Expression of Phagocytes Blood Test
What this trial is about
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Who can take part
Age range
40 Years to 80 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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)
Where it is running
1 location listed across 1 US state.
- Comprehensive Urology - Royal Oak, Michigan, United States