Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,045
- 试验地点
- 1
- 主要终点
- Performance of these models in predicting the likelihood of BCR
研究概览
简要总结
This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer
详细描述
PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the likelihood of biochemical recurrence (BCR).
SECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading and upstaging prior to surgery. II. To explore the performance of these models in improving risk stratification among patients eligible for active surveillance. III. To determine whether prostatic massage or surgery raises the count of circulating tumor cells (CTC) in post-digital rectal exam (DRE) blood specimens.
OUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE). Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •- All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be eligible for the study
排除标准
- •- Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded
研究组 & 干预措施
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: therapeutic conventional surgery (Procedure)
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: DNA analysis (Genetic)
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: DNA methylation analysis (Genetic)
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: RNA analysis (Genetic)
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: gene expression analysis (Genetic)
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: polymerase chain reaction (Genetic)
Diagnostic (specimen collection)
Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
干预措施: diagnostic laboratory biomarker analysis (Other)
结局指标
主要结局
Performance of these models in predicting the likelihood of BCR
时间窗: Visit 2 (intraoperative setting)
Logistic regression and artificial neural networks will be used.
次要结局
- Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery(Visit 2 (intraoperative setting))
- Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance(Visit 2 (intraoperative setting))
- Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens(Visit 2 (intraoperative setting))