Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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The analysis population is defined as all the set of de-identified patient results received from the practices who met the inclusion / exclusion criteria. A target recruitment of 2000 subjects with an expected loss of 20% (400 subjects) and an overall event rate of 30% (480 subjects of 1600) will result in 480 cases and 1120 controls, where cases are defined as those patients with NCCN unfavorable intermediate risk or worse disease. With a significance level alpha of 0.05, the number of cases above will result in a statistical power (1-ß=0.2) of at least 80% to show a significant increase in performance of the full assay over clinical variables alone, assuming that performance characteristics are similar to those observed in a retrospective, independent training cohort and that the patients in the SAFELY cohort resemble this same training population.

Official Title
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A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.

Conditions
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Prostate Cancer Aggressiveness

Intervention / Treatment
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* Diagnostic Test: Subtraction Normalized Expression of Phagocytes Blood Test


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 years |