NCT00987675Unknown2 期
An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of 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
- Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months
研究概览
简要总结
RATIONALE: High-intensity focused ultrasound 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 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 and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.
Secondary
- To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.
- To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.
- To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:
- •Stage ≤ T3b, N0, M0 disease
- •Gleason score ≤ 8
- •Serum PSA ≤ 20 ng/mL
- •No metastatic disease and nodal spread by staging CT or MRI
- •Negative bone scan within the past 6 months
- •Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI
- •Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved
- •PATIENT CHARACTERISTICS:
- •Able to tolerate a transrectal ultrasound
- •Able to undergo major surgery as assessed by a consultant anesthesiologist
- •Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)
- •No urethral stricture or presence of metal implants or stents in the urethra
- •No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy
- •No allergy to latex
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy
- •No prior treatment with any of the following:
- •Transurethral resection of the prostate or equivalent procedures within the past 2 years
- •High-intensity focused ultrasound ablation (HIFU)
- •Cryosurgery
- •Thermal or microwave therapy to the prostate
- •No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe
- •More than 12 months since prior androgen suppression or hormone treatment for prostate cancer
排除标准
- 未提供
结局指标
主要结局
Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months
次要结局
- Proportion of patients requiring androgen blockade at 12 months
- Success of treatment as demonstrated by the absence of cancer at 6 months
- PSA kinetics after completion of treatment
研究者
研究点 (2)
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