Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT03495427
Eligibility Criteria:
Inclusion Criteria:
* This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45).
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
* Previously enrolled to MCC#18523
* Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
* Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (\>0.45)
* Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
* Age \> 18
Exclusion Criteria:
* No follow up information available post treatment
* Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
* Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03495427
Study Brief:
Protocol Section:
NCT03495427