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- Observational
- National Cancer Institute (NCI)
- 30 - 75 Years
Study Purpose
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 genetic changes associated with prostate cancer to help them learn more about which men are at higher risk for prostate cancer. Objectives: To study men with specific genetic changes and determine who is at higher risk for getting prostate cancer. To study if certain genetic changes and family history can be used to help prevent or treat prostate cancer. Eligibility: Males between ages 30-75 who have one or more specific genetic changes but without prostate cancer. Design: * This study does not perform genetic testing. All participants must have documented genetic changes and able to provide a copy of the report. * Before enrollment, participants will provide a copy of documented genetic changes and go through a telephone interview to determine eligibility for the study. * On enrollment, participants will have medical and family history review, medication review, physical exam, blood collection for clinical and research testing, and MRI (magnetic resonance imaging) of the prostate. * Every year, participants will repeat the physical exam, medical history, family history, medication review, routine blood tests, including PSA and testosterone. * Every 2 years, participants will repeat all the above plus prostate MRI and blood tests for research. * If, at any time, the physical exam, blood tests or MRI are abnormal, participants may be asked to do a biopsy. * If the biopsy results in prostate cancer, participants will be given counseling on next steps, general treatment recommendations, and then followed with a phone call each year. * Participants may ask to speak with a genetic counselor.
Intervention
N/A
Eligibility Requirements
Persons assigned male at birth between the ages of 30-75 years.
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
Minimum age: 30
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 devic
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.
Recruiting status
Recruiting
Estimated enrollment
500
Study start date
Mar 27, 2019
Study end date
Jan 01, 2039
Last updated
Mar 24, 2025
Primary purpose
N/A
Design
Observational
Intervention
Study phase
N/A
Allocation
N/A
Sponsor:
National Cancer Institute (NCI)
Collaborator:
N/A
Investigator:
Fatima H Karzai, M.D.
N/A
Publications
Websites
NCT03805919
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