NCT00770822Unknown不适用
A Multicenter Clinical Study of the Sonablate® 500 (SB-500) for the Treatment of Localized (T1c/T2a) Prostate Cancer With HIFU
SonaCare Medical12 个研究点 分布在 1 个国家目标入组 466 人开始时间: 2007年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 466
- 试验地点
- 12
- 主要终点
- The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
研究概览
简要总结
This study will compare high intensity focused ultrasound to standard brachytherapy in the treatment of primary, organ confined prostate cancer.
详细描述
The proposed study is a prospective, non-randomized concurrently controlled study. The active treatment arm uses the HIFU procedure with the Sonablate device. The control arm uses the brachytherapy procedure. The safety and effectiveness of the Sonablate arm will be compared with the brachytherapy arm. The control arm of the study will be conducted at clinical sites different from the Sonablate arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •T1c or T2a carcinoma of the prostate confirmed by biopsy;
- •life expectancy of 5(five) years or more;
- •prostate biopsy with 10(ten) or more core biopsies;
- •Gleason score of 6(six) or less;
- •serum Prostate Specific Antigen (PSA) of 10(ten)ng/ml or less;
- •prostate volume of less than 40(Forty)cc;
- •distance from the Anterior capsule surface to the Posterior capsule surface (AP Diameter) of 40(Forty)cm or less;
- •informed consent for the treatment study through 24 months post-treatment follow-up
排除标准
- •men who have had previous definitive treatment for prostate cancer;
- •evidence of metastatic disease and/or a previous positive bone-scan, previous diagnosis or treatment for cancer within the last 5(five) years;
- •prior hormonal therapy for prostate cancer (including bilateral orchiectomy);
- •inability to tolerate a transrectal ultrasound;
- •active urinary tract infection;
- •functional bladder problems;
- •prior significant rectal surgery;
- •intra-prostatic calcifications greater than 1(One)cm in diameter;
- •interest in future fertility;
- •prostatic surgery/procedure (except biopsy) within 1(One) year;
- •large median lobe of the prostate;
- •use of medications that can affect PSA within 2(Two) months (e.g. finasteride, saw palmetto);
- •current bladder cancer, urethral stricture, or bladder neck contracture;
- •urinary tract and/or rectal fistula;
- •rectal fibrosis/stenosis;
- •anomaly of the rectal anatomy or mucus membrane;
- •prostate seroma/abcess;
- •prostatitis;
- •compromised renal function or upper urinary tract disease secondary to urinary obstruction;
- •bleeding disorders/coagulopathy based on measures of PT and PTT;
- •implant in the prostate or within 1(One)cm of the prostate;
- •zip code of the primary residence of the subject is greater than 200(Two hundred) miles from the clinical site or transportation that would hinder the completion of the study
研究组 & 干预措施
Device, HIFU
Experimental
High Intensity Focused Ultrasound
干预措施: HIFU (Sonablate® 500) (Device)
Device, brachytherapy
Active Comparator
Brachytherapy
干预措施: Brachytherapy (Device)
结局指标
主要结局
The primary endpoint will be the absence of biochemical failure, which is defined as a rise of 2.0 ng/mL or more above the PSA nadir and negative biopsy at 24 months.
时间窗: 24 Months
次要结局
未报告次要终点
研究者
研究点 (12)
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