NCT01192438已完成不适用
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 or less
- •A minimum of 12 biopsy cores sampled during diagnostic biopsy
- •Three or fewer biopsy cores with prostate cancer
- •No single biopsy core with greater than 50% of tumor involvement
- •A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
- •A documented Karnofsky performance status of at least 70
- •Estimated survival of 20 years or greater, as determined by treating physician
- •Ability to give informed consent
排除标准
- •Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
- •Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- •History of previous pelvic radiation
- •Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
- •History of other primary non-skin malignancy within previous three years
研究组 & 干预措施
Procedure/surgery
Experimental
干预措施: Laser-based thermotherapy (Procedure)
结局指标
主要结局
Number of patients with adverse events
时间窗: Within 6 months of the procedure
次要结局
未报告次要终点
研究者
研究点 (1)
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