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:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT02624518
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven prostate adenocarcinoma
* Rising 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 6-13 weeks after RP
* Confirmatory persistent PSA greater than 0.2 ng/mL
* Post-radiation therapy - American Society for Therapeutic Radiology and Oncology (ASTRO)-Phoenix consensus definition
* Nadir plus (+) greater than or equal to 2 ng/mL rise in PSA
* No evidence of metastatic disease on conventional imaging, including a negative bone scan for skeletal metastasis and negative contrast-enhanced CT
* Able to provide written consent
* Karnofsky performance status of \>= 50 (or Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] equivalent)
Exclusion Criteria:
* Unable to provide informed consent
* Inability to lie still for the entire imaging time
* Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance
* Metallic implants
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02624518
Study Brief:
Protocol Section:
NCT02624518