Focal Laser Ablation of Prostate Tissue: A Pilot Feasibility Study Using MRI/US Image Fusion for Guidance
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- safety of focal laser treatment using LITT: Number of participants with adverse events
研究概览
简要总结
This is an open-label pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal ablation of prostate tissue and to gather data for the design of future studies. Intra-procedure temperature and concurrent rectal wall thermistor monitoring will be performed for internal validation. Subjects will be monitored for adverse events, and health-related quality of life (HRQOL) questionnaires will be obtained. Post-treatment MRI and biopsies will be obtained to evaluate histologic and radiologic changes. Biomarker (PSA, PCA3 and PHI) kinetics will also be monitored.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Any significant cancer outside of MRI target (ROI) area, defined as Gleason score > 3+4
- •< 10 years life expectancy
- •American Society of Anesthesiologists (ASA) criteria of IV or higher
- •Unfit for conscious sedation anesthesia
- •Active bleeding disorder as determined by abnormal prothrombin time, partial thromboplastin time, INR or platelet count (as determined by institutional lab parameters) at the time of screening
- •Use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily reversed or stopped for a window of at least 7 days peri-procedure
- •Active urinary tract infection
- •Prostate abscess, chronic or acute prostatitis, or neurogenic bladder
- •Any prior treatment for prostate cancer
- •Radical prostatectomy
- •Radiation therapy (external beam or brachytherapy)
- •Cryotherapy
- •High intensity focused ultrasound treatment
- •Photodynamic therapy
- •Androgen deprivation therapy
- •Prior prostate, bladder neck, or urethral stricture surgery
- •Any prostate debulking procedure, including: transurethral resection of prostate, photovaporization, or electrovaporization
- •Transurethral incision of bladder neck
- •Urethral stricture dilation or reconstruction
- •Any current 5-alpha reductase inhibitors (history of use ≥ 3 months prior to MRI is acceptable)
- •Prior significant rectal surgery (hemorrhoidectomy is acceptable)
- •Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
- •Inflammatory bowel disease
- •Urinary tract or rectal fistula
- •Any contraindication to MRI (contrast allergy severe claustrophobia, MRI-incompatible prosthesis)
结局指标
主要结局
safety of focal laser treatment using LITT: Number of participants with adverse events
时间窗: 12 months
Number of participants with adverse events will be collected in the 12 month follow-up period to assess safety.
次要结局
- Efficacy of focal laser ablation of prostate tissue using the LITT system.(12 months)