Men at High Genetic Risk for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT03805919|
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : January 26, 2023
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.
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.
Persons assigned male at birth ages 30-75 who have one or more specific genetic changes but without prostate cancer.
- 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.
|Condition or disease|
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.
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.
Persons assigned male at birth who are 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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Natural History Study of Men at High Genetic Risk for Prostate Cancer|
|Actual Study Start Date :||March 27, 2019|
|Estimated Primary Completion Date :||January 1, 2029|
|Estimated Study Completion Date :||January 1, 2039|
Participants with germline pathogenic or likely pathogenic variants in prostate cancer-related risk genes
- Natural history of high genetic risk for prostate cancer [ Time Frame: one year ]To follow the natural history of men with known germline variants or likely pathogenic variants in genes that put them at high risk for developing prostate cancer
- mpMRI feasibility [ Time Frame: baseline and every two years until death or when criteria for removal from study is met ]test the feasibility and accuracy of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of local prostate cancer
- role of mpMRI [ Time Frame: baseline and every two years until death or when criteria for removal from study is met ]role of mpMRI in monitoring participants on active surveillance and as a follow up tool for monitoring local disease progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805919
|Contact: Anna C Couvillon, C.R.N.P.||(240) firstname.lastname@example.org|
|Contact: Fatima H Karzai, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 firstname.lastname@example.org|
|Principal Investigator:||Fatima H Karzai, M.D.||National Cancer Institute (NCI)|