NCT00561314已完成2 期
An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
University College London Hospitals4 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 4
- 主要终点
- Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
研究概览
简要总结
RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate.
Secondary
- To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Low-risk disease, as defined by the following criteria:
- •Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
- •Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
- •Serum PSA ≤ 15 ng/mL
- •Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
- •Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
- •All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
- •No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
- •No metastatic disease
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 5 years
- •Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
- •No prior rectal fistula
- •No American Society of Anesthesiology grades III-IV
- •No latex allergies
- •No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
- •No moderate to severe inflammatory bowel disease
- •PRIOR CONCURRENT THERAPY:
- •No androgen suppression treatment within the past 6 months
- •No transurethral resection of the prostate or laser prostatectomy within the past 5 years
- •No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
- •No prior significant rectal surgery preventing insertion of transrectal probe
排除标准
- 未提供
结局指标
主要结局
Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events
Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...
次要结局
- Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...
研究者
研究点 (4)
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