Registry trial for a blood test in managing prostate cancer
A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.
This study is testing a new blood test to see if it can help men aged 40-80 with slow-growing prostate cancer manage their condition better while they are under active surveillance.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | Male |
| Sponsor | Immunis.AI Industry-sponsored |
| Locations | 1 site (Royal Oak, Michigan) |
| Trial ID | NCT04052048 on ClinicalTrials.gov |
What this trial studies
This observational trial aims to evaluate the effectiveness of a non-invasive blood test for managing indolent prostate cancer through active surveillance. It will recruit approximately 2000 men aged 40-80 who are either currently on active surveillance or scheduled for radical prostatectomy. The study will analyze de-identified patient results to compare the performance of the blood test against traditional clinical variables. The goal is to determine if the blood test can significantly improve disease management outcomes for patients with unfavorable intermediate risk prostate cancer.
Who should consider this trial
Good fit: Ideal candidates include men aged 40-80 with a life expectancy of at least 10 years who are on active surveillance or scheduled for radical prostatectomy.
Not a fit: Patients with less than a 10-year life expectancy or those without confirmed cancer by tissue biopsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more effective and less invasive method for monitoring prostate cancer progression.
How similar studies have performed: Other studies have shown promise in using blood tests for cancer management, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Royal Oak, Michigan
- Comprehensive Urology — Royal Oak, Michigan, United States (Recruiting)
Study contacts
- Study coordinator: Jessica DeHart
- Email: jessica.dehart@oncocellmdx.com
- Phone: 619-316-1416
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.