RecruitingObservational

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

NCT ID: NCT04052048Sponsor: Immunis.AILast updated: 2026-04-02

Summary

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.

Arms & 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

Outcome measures

Primary

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 year

Secondary

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

Eligibility criteria

Sex: MaleAge: 40 Years to 80 YearsHealthy 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. 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)

Study locations (1)

Comprehensive Urology

Royal Oak, Michigan, 48197

Recruiting

Bridget Makhlouf · Contact

248-336-1080 bmakhlouf@urologist.org

Patrick Keating · Contact

248-336-1080 pkeating@urologist.org

Howard Korman, MD · Principal Investigator

References

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