Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

N/ARecruitingNCT04052048

Immunis.AI2,000 enrolled

Overview

A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Prostate Cancer Aggressiveness

Interventions

Subtraction Normalized Expression of Phagocytes Blood TestDIAGNOSTIC_TEST

Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness

Eligibility

Sex: MALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Comprehensive Urology

Royal Oak, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

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 Outcomes

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.

Time frame: 10 years

Central Contacts

Jessica DeHart

CONTACT

619-316-1416 jessica.dehart@oncocellmdx.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.