Prostate Cancer
Conditions
Brief summary
The purpose of this study is to determine the incidence of prostate cancer in men with the BRCa2 gene mutation as an independent indicator for prostate cancer screening.
Detailed description
This is a cohort screening study to prospectively identify the incidence of prostate cancer in a population of BRCA2 carriers. All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing. Standard of care screening at the Yale Cancer Center for men with a normal prostate cancer risk consists of a PSA test and prostate physical examination beginning at age 50 years and if either is abnormal an MRI of the prostate followed by Fusion-targeted biopsy of the prostate is performed.
Interventions
None listed
Sponsors
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* All men ≥30 years of age with at least a ten-year life expectancy * A known BRCA2 mutation * Ability to have an MRI * Able to give informed consent will be approached to participate in the study
Exclusion criteria
* If a man has received or is currently receiving treatment for prostate cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Prostate Cancer Patients With BRCA2 Mutation Carriers | Up to 3 years | number of patients with a BRCA2 mutation who are diagnosed with prostate cancer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BRCA2 Carriers All men identified to have a BRCA2 mutation as part of the Yale Cancer Genetic Counseling Program will be approached and offered participation in the study via our program newsletter, BRCA listserv, Facebook page and a targeted mailing | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | BRCA2 Carriers |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Number of Prostate Cancer Patients With BRCA2 Mutation Carriers
number of patients with a BRCA2 mutation who are diagnosed with prostate cancer
Time frame: Up to 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BRCA2 Carriers | Number of Prostate Cancer Patients With BRCA2 Mutation Carriers | 0 participants |