Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
Status
RECRUITING
Phase
Age
40 - 80 Years
Enrollments
2000Conditions
Prostate Cancer AggressivenessSummary
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
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.
Locations
1 location Found with status Recruiting
Eligibility Criteria
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)
Outcome Measures
Primary Outcome Measures
Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.
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.
Timeline
Last Updated
March 6, 2024Start Date
August 9, 2019Today
May 12, 2025Completion Date ( Estimated )
September 30, 2029
Sponsors of this trial
Lead Sponsor
Immunis.AI
RECRUITING 
≥ 18 Years