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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT04800068
Eligibility Criteria:
Participant Groups
There are two participant groups; please refer to the inclusion details below:
Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria):
1. Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more
2. Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)
3. Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)
Biochemically Recurrent prostate cancer group (must meet one of the criteria):
1. In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests
2. In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA
Exclusion Criteria: Current exclusion criteria for both groups includes:
1. Patients unable to sign informed consent
2. Patient with a life expectancy less than 6 months
3. Additional exclusion criteria may be added based on demand
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04800068
Study Brief:
Protocol Section:
NCT04800068