Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
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A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Condition or disease
Prostate Cancer Aggressiveness
Diagnostic Test: Subtraction Normalized Expression of Phagocytes Blood Test
This study will enroll 600 men who are currently on or are candidates for active surveillance as treatment management for their prostate cancer and are or will be scheduled for a repeat biopsy. A blood sample will be collected and undergo an immunogenomic assay to be compared to their repeat biopsy results. Subjects will then be followed for 10 years with optional serial testing at the time of their active surveillance protocol repeat biopsy. This study's hypothesis is based on the association of immunogenomic signatures from peripheral blood CD2 and CD14 cells with aggressive prostate cancer, and that this signature will identify patients with aggressive prostate cancer from a cohort of patients currently on or are candidates for active surveillance. By comparing the immunogenomic assay to the repeat biopsy information we will identify the assay's ability to predict occult aggressive cancer that would indicate the patient is no longer appropriate for continued active surveillance.
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.
Secondary Outcome Measures :
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. [ Time Frame: 10 years ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
40 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men with prostate cancer who are on or are candidates for Active surveillance.
Men between 40-80 with at least a 10-year life expectancy who based on previous prostate biopsy results are either candidates for, or are currently on active surveillance for prostate cancer.
Enrollment may be before or after any confirmatory testing.
All active surveillance protocols are accepted (Submission of written protocol required with enrollment)
No PSA limits
Patient agrees to have next surveillance biopsy (specify date or within 3 months)
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)