NCT00988130Unknown2 期
HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
University College London Hospitals2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2009年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Total proportion of men with erectile dysfunction and/or incontinence
研究概览
简要总结
RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells.
PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer.
- To evaluate the quality of life of patients treated with this regimen.
Secondary
- To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy.
- To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen.
- To evaluate the proportion of men who require androgen blockade at 12 months of follow-up.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies
- •Stage ≤ T3bN0M0
- •Gleason grade ≤ 8
- •Serum PSA ≤ 20 ng/mL
- •Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease
- •No metastatic disease and/or nodal spread by CT scan or MRI
- •Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI
- •No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy
- •PATIENT CHARACTERISTICS:
- •Able to tolerate a transrectal ultrasound
- •Not allergic to latex
- •Fit for major surgery as assessed by a consultant anaesthetist
- •Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.)
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy
- •No androgen suppression and/or hormone treatment within the past 12 months
- •No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases)
- •No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years
- •No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate
排除标准
- 未提供
结局指标
主要结局
Total proportion of men with erectile dysfunction and/or incontinence
Quality of life
次要结局
- Prostate-specific antigen kinetics
- Proportion of men requiring androgen blockade at 12 months
- Success of index lesion ablation with HIFU at 6 months
研究者
研究点 (2)
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