Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

This study is looking at a new blood test called the Subtraction Normalized Expression of Phagocytes (SNEP) Assay. This test uses RNA sequencing to identify prostate cancer and how aggressive it might be. The goal is to see how well this non-invasive blood test can find hidden aggressive prostate cancer in men who are already on active surveillance (closely watching their cancer without immediate treatment). You might be able to join if you are a man between 40 and 80 years old with at least a 10-year life expectancy, are currently on active surveillance with only one previous low-grade prostate biopsy, and are scheduled for your first annual biopsy within 90 days of joining. The study aims to collect performance results on the assay's ability to identify aggressive disease, measured at 1 year. The current status of this study is unclear.

Study design
This is an observational study planning to enroll 2000 men. It is designed to assess the performance of a blood test for managing prostate cancer.
What's involved
You must be scheduled for your first annual biopsy under your active surveillance protocol within 90 days of enrollment. The study will collect performance results on the assay's ability to identify occult aggressive disease.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 1 year, indicating follow-up for at least that duration.

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NCT04052048

Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

Recruiting
Not specifiedAges 40–80Observational
Immunis.AI
~2,000 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:Subtraction Normalized Expression of Phagocytes Blood Test

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population.
Measured over 1 year
Prostate Cancer Aggressiveness
1 sites across 1 states
Michigan1

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Eligibility criteria

Inclusion

Men between 40-80 of age with at least a 10-year life expectancy
All active surveillance protocols are accepted
No PSA limits
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.

Exclusion

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)
  • 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.