Status:
RECRUITING
Active Surveillance SNEP Assay Registry Trial for Prostate Cancer
Lead Sponsor:
Immunis.AI
Conditions:
Prostate Cancer Aggressiveness
Eligibility:
MALE
40-80 years
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
September 9 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2029
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04052048
Start Date
September 9 2019
End Date
September 30 2029
Last Update
March 6 2024
Active Locations (1)
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1
Comprehensive Urology
Royal Oak, Michigan, United States, 48197