Precision Medicine in the Prostate Cancer Care Pathway: an Evaluation of Integrating Germline Genetic Testing Into the Management of Men at Risk of / Living With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Prevalence of genetic variation in affected men
研究概览
简要总结
This study aims to evaluate the use of a prostate cancer specific predisposition genetic panel test in men with / at high risk of prostate cancer. The genetic test will analyse men's DNA samples for the presence of mutations in rare genes as well as common genetic variation to provide men with information about their risk of prostate cancer. This study will evaluate the clinical impact of the test on risk assessment and clinical management in terms of screening and treatment.
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
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Affected cohort:
- •Affected with PrCa < 60 years or
- •Affected with metastatic castration resistant PrCa (mCRPC) at any age or Aggressive PrCa Gleason 4+4 or higher <70 years
- •Affected with family history defined as three or more cases any age (FDR or SDR)
- •Unaffected cohort: (This cohort is no longer recruiting, it has completed recruitment)
- •Aged >30 and with a family history defined as:
- •FDR diagnosed < 70
- •2 or more cases in First or Second Degree Relatives (FDR/SDR) with one case diagnosed < 70 years
- •3 or more cases at any age (on same side of family)
排除标准
- •• WHO performance status 4
结局指标
主要结局
Prevalence of genetic variation in affected men
时间窗: Through study completion, an average of 1 year
To determine the prevalence of prostate cancer (PrCa) specific genetic variation in men with: (a)young onset PrCa; (b) metastatic PrCa; (c) men with PrCa and a family history of PrCa compared with controls.
次要结局
- Prostate Cancer genetic variation on clinical outcome(Through study completion, an average of 1 year)
- Prevalence of genetic variation in unaffected men(Through study completion, an average of 1 year)