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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03805919.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: Anna Couvillon
Phone: 240-858-3148
Background:
Prostate cancer is the most common malignancy and the second leading cause of
cancer-related deaths in American men.
Prostate cancer has substantial inherited predisposition and certain genetic variants
that are associated with an increased risk of prostate cancer.
An evolving approach to prostate cancer screening is to target populations at risk of
developing prostate cancer based on their genetic predisposition.
Objective:
To follow the natural history of men with known germline variants or likely pathogenic
variants in genes that put them at risk for developing prostate cancer.
Eligibility:
Males between ages 30-75 years old.
Documented germline pathogenic or likely pathogenic variants in prostate cancer-related
risk gene: BRCA 1 and 2, DNA Mismatch Repair (MMR) genes associated with Lynch syndrome
(MLH1, MSH2, MSH6, PMS2, and EPCAM), HOXB13, ATM, NBN, TP53, CHEK2, PALB2, RAD51C,
RAD51D, BRIP1, or FANC (FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL,
and FANCM).
Must be able and willing to provide informed consent.
Design:
Up to 500 subjects will be enrolled.
Participants will undergo sampling of blood for prostate-specific antigen. Based on these
results and age, participants will be considered for biopsy and/or continued monitoring
if feasible upon clinical discretion.
Participants will undergo a baseline MRI evaluation with follow-up scans every 2 years as
clinically indicated.
Following initial evaluation, participants will be followed as clinically indicated,
usually at 12 month intervals, to determine their PSA level, prostate cancer treatment
(if relevant) and/or disease/survival status until death.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorWilliam L. Dahut
