Monitoring prostate health in men with high genetic risk for prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to follow the prostate health of men aged 30-75 who have specific genetic changes associated with an increased risk of prostate cancer. Participants must have documented germline variants in genes such as BRCA1, BRCA2, and MMR genes linked to Lynch syndrome. The study will involve blood sampling for prostate-specific antigen and MRI evaluations to monitor prostate health over time. The goal is to better understand which genetic factors contribute to higher prostate cancer risk and how they can inform prevention and treatment strategies.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Fatima H Karzai, M.D. — National Cancer Institute (NCI)
• Study coordinator: Anna C Couvillon, C.R.N.P.
• Email: couvilla@mail.nih.gov
• Phone: (240) 858-3148

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.