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:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT05384535
Eligibility Criteria:
Inclusion Criteria:
1. PSA between 1.0 and 2.5 ng/dL
2. High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2
3. Patient is willing to participated in prostate cancer screening
4. Patient is capable of giving informed consent
Exclusion Criteria:
1. Nodularity or firmness of prostate on exam
2. Patient has undergone a prior biopsy or prostate surgery
3. Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
4. Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
5. Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
6. Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
7. The participant cannot tolerate lying flat for the study duration
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT05384535
Study Brief:
Protocol Section:
NCT05384535