High-Intensity Focused Ultrasound for Focal Ablation of Prostate Tissue: An Observational Study of Multiparametric MRI and Ultrasound Fusion Imaging for Guidance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oncological Response
研究概览
简要总结
The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.
详细描述
This observational study will serve to collect data from medical record review and questionnaires before and after High Intensity Focused Ultrasound (HIFU) for focal ablation of prostate tissue. The subject will have already undergone or opted to receive the HIFU procedure as part of standard of care in order to participate in this study.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 40 years to 85 years
- •Subject has elected or already undergone HIFU therapy as their standard of care treatment methodand declined alternative treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
- •Prostate volume of ≤ 70 cc
- •Ability to complete informed consent form
排除标准
- •Prior treatment for prostate cancer (with the exception of androgen deprivation therapy)
- •Medical contraindication to follow-up mpMRI or prostate biopsy
- •Unable to tolerate general or regional anesthesia
- •Positive bone scan (only if bone scan has been done or clinically indicated. Bone scan does not need to be performed for study eligibility determination.)
研究组 & 干预措施
HIFU Study Participants
Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the HIFU procedure as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study. The HIFU device currently used in this standard-of-care procedure at UCLA is the Sonablate 450 HIFU System.
干预措施: Sonablate HIFU device (Device)
结局指标
主要结局
Oncological Response
时间窗: 6 months
The following definitions will be used for evaluation of oncological response: 1. Complete response: Ablation of prostate tissue in targeted biopsy cores at 6 months and 18 months post-procedure biopsy and resolution of initial mp-MRI abnormality. 2. Incomplete radiographic response: Residual mp-MRI abnormality at 6 months compared to baseline 3. Local failure: Failure to ablate prostate tissue
次要结局
- Decisional Regret Scale(18 months)
- Evaluation of Quality-of-Life Symptoms (EPIC-CP)(18 months)
- Evaluation of Quality-of-Life Symptoms (EPIC-CP)(6 months)
研究者
Leonard S. Marks, M.D.
Principal Investigator
University of California, Los Angeles