Prostate Cancer
Conditions
Brief summary
The EMPOWeR study is proposed as a cohort study with longitudinal follow-up to determine rates of genetic mutations among men with or at-risk for prostate cancer to address the various facets of genetic education and counseling for optimized genetic assessment and wellness of men. The results will inform practice guidelines and future studies for maximal impact of genetic evaluation of men for inherited prostate cancer.
Interventions
None listed
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men with a personal history of prostate cancer * Unaffected males who are at higher risk for prostate cancer (family history of prostate cancer or African American males) * Men who previously tested positive for a mutation may be eligible for Specific Aims 2-7 * Men with a known familial mutation * Men who previously participated in the Genetic Evaluation of Men (GEM) study (IRB#14S.546) will be offered participation in EMPOWeR -
Exclusion criteria
* Age \< 18 years * Mental or cognitive impairment that interferes with ability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics. | 6 months | Participants will undergo gene panel testing through a saliva or blood sample. A genetic test summary will be generated to give to participants at disclosure of results. Participants will receive genetic test results in person, by phone or via telehealth. Fisher's exact test will be used to determine association of mutations and variants to patient characteristics. |
Countries
United States
Outcome results
None listed