NCT00561262已完成2 期
An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
University College London Hospitals2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年5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
- 60
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue.
PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.
详细描述
OBJECTIVES:
Primary
- To determine patient acceptability, feasibility, and side-effect profile by evaluating records of adverse events.
- To determine patient acceptability, feasibility, and side-effect profile by evaluating urinary symptoms and erectile function before study stage 1 (verification), before study stage 2 (treatment), and at each follow-up visit.
Secondary
- To determine the effectiveness of therapy by post-treatment transrectal ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure.
- To determine the effectiveness of therapy by post-treatment MRI to evaluate area of necrosis and presence of any residual tissue.
- To determine the effectiveness of therapy by measurement of prostate-specific antigen (PSA) at each follow-up visit and measurement of time to PSA nadir.
- To determine the effectiveness of therapy 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
- — 至 79 Years（Child, 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, meeting the following criteria:
- •Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable)
- •Cancer prostate-confined only
- •Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy
- •Serum prostate-specific antigen (PSA) ≤ 15 ng/mL
- •Prostate volume ≤ 40 cc OR AP length of prostate < 4 cm
- •Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence MRI and transperineal template biopsies outside of this trial in similar procedure protocols to this trial
- •No evidence of metastatic disease
- •No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 5 years
- •No latex allergies
- •No American Society of Anesthesiology surgical risk score III or IV
- •No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images)
- •Must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist
- •PRIOR CONCURRENT THERAPY:
- •More than 6 months since prior androgen suppression therapy
- •No prior radiotherapy for prostate cancer
- •No prior chemotherapy for prostate cancer
- •No prior significant rectal surgery preventing insertion of transrectal probe
- •No prior transurethral resection of the prostate or laser prostatectomy
- •No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate
排除标准
- 未提供
结局指标
主要结局
Feasibility
Adverse events
Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function
Side effect profile
次要结局
- Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir
- Exclusion of cancer on MRI at 2-7 days and at 6 months
- Transrectal ultrasound biopsies at 6 months
- Need for secondary or adjuvant treatment for prostate cancer following therapy
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
High-Intensity Focused Ultrasound Ablation in Treating Patients With Localized Prostate CancerUrinary IncontinenceProstate CancerSexual DysfunctionNCT00561314University College London Hospitals33
终止
3 期
Ultrasound in Treating Patients With Recurrent Stage I or Stage II Prostate CancerProstate CancerNCT00005075EDAP Technomed
Unknown
2 期
High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate CancerProstate CancerNCT00987675University College London Hospitals26
终止
不适用
Pilot Study of a Catheter-based Ultrasound Hyperthermia SystemCervical CancerProstate CancerNCT00911079University of California, San Francisco13
Unknown
2 期
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate CancerProstate CancerSexual DysfunctionNCT00988130University College London Hospitals26