Evaluation and Management for Prostate Oncology, Wellness, and Risk (EMPOWeR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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 -
排除标准
- •Age < 18 years
- •Mental or cognitive impairment that interferes with ability to provide informed consent
结局指标
主要结局
Perform genetic testing for men with or at-risk for prostate cancer to determine association of mutations to patient characteristics.
时间窗: 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.
次要结局
未报告次要终点