A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.
详细描述
The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 45 years of age or older.
- •Diagnosis of prostate adenocarcinoma.
- •Clinical stage T1c or T2a.
- •Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
- •PSA less than or equal to 20 ng/mL
- •Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
- •No lesion > or = 2cm
- •One, two, or three tumor suspicious regions identified on multiparametric MRI
- •No definite radiographic indication of extra-capsular extension.
- •Estimated survival of 5 years or greater, as determined by treating physician.
- •Tolerance for anesthesia/sedation.
- •Ability to give informed consent.
排除标准
- •Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
- •History of other primary non-skin malignancy within previous three years.
研究组 & 干预措施
Single arm study
MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
干预措施: Focal laser ablation of the prostate (Procedure)
结局指标
主要结局
Success rate
时间窗: 3 years
To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.
Incidence of treatment emergent adverse events
时间窗: 3 years
To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.
次要结局
- Short- and mid-term ablative success(3 years)
研究者
David A. Woodrum
David A. Woodrum, M.D., Ph.D.
Mayo Clinic