CLINICAL UTILITY OF AXUMIN PET/MRI IMAGING TWO YEARS FOLLOWING FOCAL CRYO-ABLATION (FCA) OF PROSTATE CANCER
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
研究概览
简要总结
This is a prospective outcomes study assessing quality of life and oncological control at pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years following FCA. The prostate biopsy assesses both the presence of in field and out of field disease. The role of Axumin PET/MRI for detecting disease following FCA has not been previously examined.
详细描述
The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of in field recurrence of significant prostate cancer defined as any Gleason pattern 4 disease.
The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years following FCA will improve sensitivity for detection of out of field recurrence of significant prostate cancer .
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •FCA at NYU Langone Health performed at least two years prior to study enrollment by Drs. Lepor or Wysock.
- •No prostate cancer specific treatment following FCA
- •Consented to undergo reflex MRI and prostate biopsy two years following FCA.
排除标准
- •Any contraindication to prostate biopsy
- •Prior allergic reaction to 18F-Fluciclovine
- •Patient refuses MRI and prostate biopsy two years following FCA.
结局指标
主要结局
Measure of sensitivity following PET imaging with 18-F fluciclovine (Axumin)
时间窗: 1 Day
次要结局
未报告次要终点