Recruiting

Observational Study

Sponsor:

Immunis.AI

Code:

NCT04052048

Conditions

Prostate Cancer Aggressiveness

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Subtraction Normalized Expression of Phagocytes Blood Test

Study Details

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.

Conditions

Prostate Cancer Aggressiveness

Study ID

NCT04052048

Start date

Sep 9, 2019

Status verified date

Mar, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Nov 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not 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)

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Subtraction Normalized Expression of Phagocytes Blood Test

Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness

Primary outcome measure

  • Collect performance results on assay's ability to identify occult aggressive disease in active surveillance population. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Comprehensive Urology

Recruiting

Royal Oak, Michigan, United States, 48197

Contacts

Principal Investigator:

Howard Korman, MD

More Information

Sponsor

Immunis.AI

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Immunis.AI on 2026-04-02.