Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Diagnosis of prostate cancer
研究概览
简要总结
This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.
详细描述
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 men harboring specific genetic variants or a positive family history have been associated with an increased risk of developing prostate cancer. Men with specific genetic variants, such as pathogenic BRCA2 mutations, are at particularly greater risk of developing aggressive forms of prostate cancer and thus warrant undergoing careful screening for prostate cancer. However, the penetrance of many mutations in prostate cancer risk genes is unknown, and some men have no identifiable mutations in known risk genes despite a strong family history of prostate cancer. Prospectively collected clinical data along with biospecimens from unaffected individuals at high genetic risk for developing prostate cancer will advance the understanding of how specific mutations contribute to the development of prostate cancer and how these prostate cancers might be best detected. The purpose of this study is to prospectively screen men at high risk genetic risk for prostate cancer by prostate exam, PSA, and prostate MRI to characterize the penetrance and cancer-related outcomes of specific mutations, identify potentially novel genetic risk mutations and/or markers for early detection.
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
- 35 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 35-74 years old
- •No known diagnosis of prostate cancer
- •Life expectancy >10 years
- •Meet cohort A, B, or C criteria
- •Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)
- •Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing
- •Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry
排除标准
- •Prior diagnosis or treatment of prostate cancer
- •Inability to undergo prostate MRI
- •Inability to receive MRI contrast agent
结局指标
主要结局
Diagnosis of prostate cancer
时间窗: From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first
Diagnosis of overall and clinically significant (grade group 2 or higher) prostate cancer
次要结局
- Positive predictive value of multiparametric MRI for detection of prostate cancer(From date of enrollment until date of diagnosis of prostate cancer or age of 75 reached, which ever came first)
研究者
Keyan Salari, MD, PhD
Urologic Oncology
Massachusetts General Hospital