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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT05653856
Eligibility Criteria:
Inclusion Criteria:
1. Patients with histologically proven prostate adenocarcinoma.
2. Prior radical prostatectomy or radiation therapy with curative intent.
3. Recurrence of disease defined as:
1. Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or
2. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
4. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
5. Age greater than or equal to 18 years.
6. Able to understand and provide signed written informed consent.
Exclusion Criteria:
1. Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
2. Body weight greater than 350 lb (158 kg).
3. Investigational therapy within the past 30 days.
4. Creatinine clearance (ClCr) less than 30 mL/min.
5. Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT05653856
Study Brief:
Protocol Section:
NCT05653856