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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT02918357
Eligibility Criteria:
Inclusion Criteria:
* Histopathological proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
* Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation
* PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
* Confirmatory persistent PSA greater than 0.2 ng/mL
* Post-radiation therapy -ASTRO-Phoenix consensus definition
* Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
* Age \> 18.
* Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a PET scan.
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
* Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02918357
Study Brief:
Protocol Section:
NCT02918357