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 @ 3:10 AM
Ignite Modification Date:
2025-12-25 @ 3:10 AM
NCT ID:
NCT05129605
Eligibility Criteria:
Inclusion Criteria:
* Men 35-74 years old
* No known diagnosis of prostate cancer
* Life expectancy \>10 years
* Meet cohort A, B, or C criteria
* Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
* Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
* Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
Exclusion Criteria:
* Prior diagnosis or treatment of prostate cancer
* Inability to undergo prostate MRI
* Inability to receive MRI contrast agent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
35 Years
Maximum Age:
74 Years
Study:
NCT05129605
Study Brief:
Protocol Section:
NCT05129605