NCT04052048 · Immunis.AI
Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
What this study is about
A multi-center, forward-looking active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
View original scientific description
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Interventions
DIAGNOSTIC_TEST
Subtraction Normalized Expression of Phagocytes Blood Test
Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness
Primary outcome measures
Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Royal Oak, Michigan
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations