Natural History Study of Men at High Genetic Risk for Prostate Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
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 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Anna C Couvillon, C.R.N.P.
couvilla@mail.nih.gov
(240) 858-3148
Backup
Fatima H Karzai, M.D.
fatima.karzai@nih.gov
(301) 480-7174
Time Frame
Start Date: 2019-03-27
Estimated Completion Date: 2039-01-01
Participants
Target number of participants: 500
Treatments
Cohort 1
Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov