Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
ConditionProstate Cancer Aggressiveness
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40-80
SponsorImmunis.AI
About this trial
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men between 40-80 of age with at least a 10-year life expectancy
All active surveillance protocols are accepted
No PSA limits
Patient is currently on active surveillance with only ONE previous low grade prostate biopsy.
Disqualifiers
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)
Trial population
Men with prostate cancer who are on or are candidates for Active surveillance.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Subtraction Normalized Expression of Phagocytes Blood Test
Diagnostic testNon-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.
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.
Time frame
1 yearSecondary outcomes
1
Validate immunogenomic assay's ability to serve as an ongoing, non-invasive tool to monitor patient risk for disease progression as detected by repeat biopsy.
On an annual basis, collect follow-up frequency data for each patient including optional repeat blood testing, repeat biopsy data, disease management decisions, and disease progression.
Time frame
10 years Source ClinicalTrials.gov