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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT03389451
Eligibility Criteria:
Inclusion Criteria:
* Pathologically proven prostate adenocarcinoma
* Rising prostate-specific antigen (PSA )after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
* If post-radical prostatectomy, PSA \> 0.2 ng/mL measured \> 6 weeks post-operative and confirmed persistent PSA \> 0.2 ng/mL (AUA recommendation for biochemical recurrence)
* If post-radiation therapy, PSA that is ≥ 2 mg/mL rise above PSA nadir (ASTRO recommendation for biochemical recurrence)
* Not receiving any other investigational agents (i.e., unlabeled drugs or drugs under an IND for initial efficacy investigations)
* No other malignancy within the past 2 years (skin basal cell or cutaneous superficial squamous cell carcinoma or superficial bladder cancer are exempt from this criterion)
* Karnofsky performance status (KPS) ≥ 50 (ECOG/WHO of 0, 1, or 2)
* Ability to understand and willingness to provide informed consent
Exclusion Criteria:
* Cannot receive furosemide
* History of Stevens Johnson syndrome
* History or diagnosis of Paget's disease
* Malignancy other than current disease under study
* Allergy to sulfa or sulfa-containing medications
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03389451
Study Brief:
Protocol Section:
NCT03389451