MRI-Guided Cryoablation for Focal Native Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Safety of the MR-guided cryoablation
研究概览
简要总结
The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed.
Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.
详细描述
The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits.
The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.
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
- 30 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
- •Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
- •Tumor size is < 2 cm at its largest diameter
- •Tumor does not encompass the rectal wall or external urethral sphincter
- •Patient is able to undergo MRI
排除标准
- 未提供
结局指标
主要结局
Safety of the MR-guided cryoablation
时间窗: Will assess for 5 years with interval assessment each year
Determine safety of the MR-guided cryoablation using continuous MR imaging during the procedure.
Examine short term tumor recurrence
时间窗: Will assess for 5 years with interval assessment each year
Examine short term tumor recurrence over 6 months with contrast enhanced MRI and as required MR or U/S guided biopsy of prostate bed if PSA biochemical recurrence.
Technical success of the MR-guided cryoablation
时间窗: Will assess for 5 years with interval assessment each year
Determine the technical success of the MR-guided cryoablation as measured by complete target lesion ablation.
次要结局
- MR procedure time.(Will assess for 5 years with interval assessment each year)
研究者
David A. Woodrum
M.D, Ph.D, Principal Investigator
Mayo Clinic