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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT04936334
Eligibility Criteria:
Inclusion Criteria:
* 1\. Men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. Prostate pathology results consistent with:
1. \> 3 cores of Gleason 3+4 or
2. NCCN unfavorable intermediate risk or
3. NCCN high-risk or
4. NCCN very-high risk 3. Scheduled for standard of care MRI or has recently completed standard of care MRI (within 6 months).
Willing and able to lie still for approximately 50 minutes in an enclosed space for the PET/CT and MRI
Exclusion Criteria:
* 1\. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
2\. Does not meet safety criteria for MRI scan (e.g. metal implant that could affect prostate imaging).
3\. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04936334
Study Brief:
Protocol Section:
NCT04936334