NCT02224911已完成不适用
Use of Laser Interstitial Thermal Therapy in the Focal Treatment of Localized Prostate Cancer: A Pilot Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of safety and tolerability
研究概览
简要总结
This is a pilot, feasibility/exploratory study to evaluate the safety of laser interstitial thermal therapy (LITT) using Visualase in the focal treatment of localized prostate cancer as well as to gather data for the design of future studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects with initial presentation of organ confined prostate cancer (clinical stage ≤ T2b)
- •Negative metastatic workup with bone scan and CT abdomen/pelvis, within 6 months of study treatment, if indicated by PSA >10
- •Age 40 years to 85 years of age
- •Multi-parametric MRI at UCLA within 6 months of study treatment, demonstrating a
- •Region of interest (ROI) of MRI suspicion level 3 or higher
- •ROI located proximal to the external sphincter by a margin of at least 2 cm
- •Transrectal ultrasound-guided biopsy with ≥ 10 systematic biopsy cores and ≥ 2 MRI-ultrasound fusion targeted biopsy cores from above MRI-derived ROI
- •Histologically-confirmed adenocarcinoma from targeted biopsy cores (≥ 2 cores)
- •Overall Gleason score not to exceed 3+4
- •Subjects desire focal therapy and declined conventional treatment (active surveillance, radical prostatectomy, radiation therapy, cryosurgery and hormone therapy)
- •Signed informed consent for the LITT treatment through the 12 month follow up visit
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 ≥ 6 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
- •History of 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
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 12 months
次要结局
- Absence of prostate cancer in the MRI target area as measure of efficacy.(12 months)
研究者
研究点 (1)
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