Men at High Genetic Risk for Prostate Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/4/2019 |
| Start Date: | March 27, 2019 |
| End Date: | January 1, 2039 |
| Contact: | Anna C Couvillon, C.R.N.P. |
| Email: | couvilla@mail.nih.gov |
| Phone: | (240) 858-3148 |
Natural History Study of Men at High Genetic Risk for Prostate Cancer
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:
Men ages 30 70 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 with digital rectal exam (DRE), 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, DRE, 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.
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:
Men ages 30 70 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 with digital rectal exam (DRE), 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, DRE, 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.
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:
- Men who are between ages 30-70 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, HOXB13, ATM or NBN, TP53.
-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 and digital
rectal exam. Based on these results and age, patients 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.
- 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:
- Men who are between ages 30-70 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, HOXB13, ATM or NBN, TP53.
-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 and digital
rectal exam. Based on these results and age, patients 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.
- Inclusion Criteria:
- Men between the ages of 30-70 years.
- 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, HOXB13, ATM or
NBN, and TP53.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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