Men at High Genetic Risk for Prostate Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jan 15, 2019

Keywords

ClinConnect Summary

This clinical trial is studying men who have specific genetic changes that may put them at a higher risk for prostate cancer. Researchers want to understand how these genetic changes and family history can help identify which men are more likely to develop prostate cancer. The trial is open to men aged 30 to 75 who have been assigned male at birth and have documented genetic changes linked to prostate cancer, but who do not currently have the disease.

If you decide to participate, you will first need to provide proof of your genetic changes and complete a phone interview to see if you qualify. Once enrolled, you’ll undergo a review of your medical and family history, a physical exam, and some blood tests. You'll also have an MRI scan of your prostate. After that, you’ll return for similar check-ups every year and additional tests every two years. If any tests show something unusual, you might need a biopsy to check for cancer. If cancer is found, you will receive counseling on what to do next. Additionally, you can speak with a genetic counselor if you have questions about your genetic risk. This trial is currently recruiting participants, so you could play an important role in advancing our understanding of prostate cancer risk.

Gender

MALE

Eligibility criteria

• * Inclusion Criteria:
• • 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 Criteria:
• • 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.