Precision Medicine for Early Prostate Cancer: Integrating Biological and Patient Complexity Variables to Predict Treatment Response
试验速览
- 阶段
- 不适用
- 入组人数
- 693
- 试验地点
- 5
- 主要终点
- Prostate-Cancer-specific change in quality of life
研究概览
简要总结
This study will replicate/validate the risk prediction model developed for the Comparative Effectiveness Analysis of Surgery and Radiation (CEASAR) study in a more diverse patient population to assess generalizability of the model as well as evaluate the relative contribution of the Decipher Prostate Cancer Test and ProstateNext Test from Ambry Genetics, to the risk prediction model for estimating treatment outcomes, and thereby improve personalization of treatment options.
详细描述
The study will contribute a replicable model for improving risk prediction from patient characteristics, clinical severity indicators, and genomic tests to aid in personalizing treatment. The proposed registry would also allow future comparisons of the gene expression used in other competing commercial test. The addition of the suggested genomic classifier and its associations with other patient and clinical characteristics will enhance the ability of future studies, analogous to CEASAR, to accurately predict the risk of tumor aggressiveness in 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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18 - 90 years of age
- •Prostate-Specific Antigen (PSA) values <50ng/ml
- •Clinical stage of T1 or T2
- •No evidence of metastasis or nodal involvement
排除标准
- •Age 91 or greater
- •Clinically locally advanced or metastatic disease
- •PSA equal to or greater than 50ng/ml
- •Diagnosis of malignancy (excluding squamous or basal cell carcinoma of the skin) within 3 years of diagnosis of prostate cancer
结局指标
主要结局
Prostate-Cancer-specific change in quality of life
时间窗: Day of enrollment, 6-months, and 12-months after enrollment
Quality of life is measured by the Expanded Prostate Cancer Index Composite (EPIC). The Expanded Prostate Cancer Index Composite \[EPIC\] is a validated instrument for measuring disease-specific function/ The domain scores range from 0 to 100, with higher scores representing better function. Patients will be asked to complete the questionnaires during a consultation visit or remotely. EPIC scores will be collected at baseline, 6 month follow up, and at 12 month follow up via the questionnaire. EPIC scores from each time point will then be compared to look at the change in quality of life over the duration of the study.
次要结局
- Recurrence of cancer(EMR data abstraction around the 6-month time point after enrollment)
- Complications of treatment(EMR data abstraction around the 6-month time point after enrollment)