Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

Recruiting now

Conditions studied: Prostate Cancer Aggressiveness

In brief

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

Key facts

Study ID

NCT04052048

Run by

Immunis.AI

People needed

2000

Starts

2019-09-09

Expected to finish

2029-09-30

Last updated by the study team

2026-04-02

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• Comprehensive Urology — Royal Oak, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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