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 @ 7:30 PM
Ignite Modification Date:
2025-12-24 @ 7:30 PM
NCT ID:
NCT04447703
Eligibility Criteria:
Inclusion Criteria
* AIM 1: Medical oncologists, radiation oncologists and urologists spanning Veterans Affairs (VA), academic, and community settings
* AIM 2: Any English speaking man \>= 18 with PCA who has computer and web-access and meets any one of the following:
* Metastatic disease
* T3a or higher
* Prostate specific antigen (PSA) \> 20
* Grade group 4 or higher
* Intraductal or cribriform histology
* Biochemical recurrence
* Ashkenazi Jewish ancestry
* Family history criteria (see below) \*\* Family history: If any one of the following levels are met, the person is eligible:
* Level 1: \>= 1 close blood relative (first degree relative \[FDR\], second degree relative \[SDR\], third degree relative \[TDR\]) diagnosed with breast cancer =\< age 50 or the following cancers at any age: pancreatic, ovarian, or metastatic or intraductal/cribriform prostate cancer
* Level 2: \>= 2 close blood relatives (FDR, SDR, TDR) on same side of the family with breast or prostate cancer at any age
* Level 3: one brother, father, or \>= 2 family members (close blood relatives - FDR, SDR, TDR) on the same side of the family diagnosed with prostate cancer at \< 60
* Level 4: \>= 3 cancers on the same side of the family (especially if diagnosed =\< 50): bile duct, breast, colorectal, endometrial, gastric, kidney, melanoma, ovarian, pancreatic, prostate (grade groups 2-5 if known), small bowel, or urothelial
Exclusion Criteria
* Age \< 18 years
* Mental or cognitive impairment that interferes with ability to provide informed consent
* Non-English speaking
* Having had prior germline genetic testing for inherited cancer risk (pertains to aim 2)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04447703
Study Brief:
Protocol Section:
NCT04447703