Monitoring prostate health in men with high genetic risk for prostate cancer
Natural History Study of Men at High Genetic Risk for Prostate Cancer
This study is trying to see how the prostate health of men aged 30-75 with certain genetic changes linked to a higher risk of prostate cancer changes over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT03805919 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are males aged 30-75 with documented germline variants in prostate cancer-related risk genes.
Not a fit: Patients who have already been diagnosed or treated for prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and preventive measures for men at high genetic risk for prostate cancer.
How similar studies have performed: Other studies have shown success in targeting high-risk populations based on genetic predisposition, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.