Status:
RECRUITING
Men at High Genetic Risk for Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
30-75 years
Brief Summary
Background: Research studies have shown that genetic changes and family history may increase a man s risk for prostate cancer. Researchers want to follow the prostate health of men who have specific ...
Detailed Description
Background: Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. Prostate cancer has substantial inherited predisposition and certain ...
Eligibility Criteria
Inclusion
- Males between ages 30-75 years old.
- Documented germline variant (i.e. pathogenic/likely pathogenic variant) in prostate cancer risk-related gene from a CLIA certified laboratory: BRCA1 and BRCA2, MMR genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) associated with Lynch syndrome, as well as HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C, RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, and FANCM).
- Prognosis of \>5 years survival if affected by another cancer
- Ability of subject to understand and the willingness to sign a written informed consent document
Exclusion
- Prior diagnosis or treatment for prostate cancer
- Known contraindication to MRI:
- Participants unable to fit through MRI scanner (radiologist discretion)
- Allergy to MR contrast agent
- Participants with pacemakers, cerebral aneurysm clips, shrapnel injury, or implantable electronic device
- Active concomitant medical or psychological illnesses that may increase the risk to the subject or inability to obtain informed consent, at the discretion of the principal investigator.
Key Trial Info
Start Date :
March 27 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2039
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03805919
Start Date
March 27 2019
End Date
January 1 2039
Last Update
January 8 2026
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892