Men at High Genetic Risk for Prostate Cancer
ConditionProstatic Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-75
SponsorNational Cancer Institute (NCI)
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Prior diagnosis or treatment for prostate cancer
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
Trial population
Men with a documented germline variant in prostate cancer risk-related gene from a CLIA certified laboratory
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Cohort 1
Trial outcomes
Primary outcomes
1
Natural history of high genetic risk for prostate cancer
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
Time frame
one yearSecondary outcomes
1
mpMRI feasibility
test the feasibility and accuracy of multi parametric magnetic resonance imaging (mpMRI) for the localization and detection of local prostate cancer
Time frame
baseline and every two years until death or when criteria for removal from study is met2
role of mpMRI
role of mpMRI in monitoring participants on active surveillance and as a follow up tool for monitoring local disease progression
Time frame
baseline and every two years until death or when criteria for removal from study is metSponsors and contacts
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Source ClinicalTrials.gov