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Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

RECRUITINGSponsored by Immunis.AI
Actively Recruiting
SponsorImmunis.AI
Started2019-09-09
Est. completion2025-11-15
Eligibility
Age40 Years – 80 Years
SexMALE
Healthy vol.Accepted
Locations1 site

Summary

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

Eligibility

Age: 40 Years – 80 YearsSex: MALEHealthy volunteers accepted
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)

Conditions2

CancerProstate Cancer Aggressiveness

Locations1 site

Comprehensive Urology
Royal Oak, Michigan, 48197
Bridget Makhlouf248-336-1080bmakhlouf@urologist.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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