A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.
Immunis.AI
Summary
A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.
Description
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 p…
Eligibility
- Age range
- 40–80 years
- Sex
- Male
- Healthy volunteers
- No
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.…
Interventions
- Diagnostic TestSubtraction Normalized Expression of Phagocytes Blood Test
Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness
Location
- Comprehensive UrologyRoyal Oak, Michigan