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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT02673151
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 Urology Association (AUA) recommendation
* PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
* Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
* Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition
* A rise of PSA measurement of 2 or more ng/mL over the nadir
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)
* Able to provide written consent
Exclusion Criteria:
* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a positron emission tomograpy (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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02673151
Study Brief:
Protocol Section:
NCT02673151