Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of PSA elevation after DRE
研究概览
简要总结
Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination
详细描述
Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA < 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination.
The change of PSA will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Intact Rectum
- •Prostate Cancer eligible for active surveillance
排除标准
- •Pror radiation therapy
- •Under Androgen Deprivation Therapy
- •Prior prostate surgery
研究组 & 干预措施
Active Surveillance
Patients with known prostate cancer eligible for active surveillance Intervention - PSA measurement
干预措施: Blood test (PSA) (Other)
Controls
Patients without known diagnosis of prostate cancer Intervention - PSA measurement
干预措施: Blood test (PSA) (Other)
结局指标
主要结局
Percentage of PSA elevation after DRE
时间窗: 1 hour
次要结局
未报告次要终点
研究者
Dr Uri Lindner
Dr. Uri Lindner, Staff Urologist, Kaplan Medical Center
Kaplan Medical Center