Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

Recruiting

• Conditions: Prostate Cancer Aggressiveness

• Registration Number: NCT04052048
• Lead Sponsor: Immunis.AI

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Study Start: 2019-09-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-11-15
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
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.	10 years	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.

Trial Locations

Locations (1)

Comprehensive Urology; 🇺🇸 Royal Oak, Michigan, United States