Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue.
PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.
详细描述
OBJECTIVES:
- Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with organ-confined prostate cancer.
OUTLINE: This is a multicenter study.
A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken at least 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU.
Patients are followed at 2, 14, 30, 90, and 180 days.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 40 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 organ-confined prostate cancer (clinical stage T1 or T2 only)
- •Pretreatment prostate weight less than 40 g
- •Gleason score no greater than 7
- •PSA no greater than 10 ng/mL
- •No significant intravesical median lobe (greater than 2 cm) on ultrasound
- •Able to visualize prostate gland adequately on transrectal ultrasound imaging
- •No prostate calcification greater than 5 mm
- •No metastases by bone scan
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •No bleeding disorder as determined by abnormal PT and PTT
- •No active urinary tract infection
- •No history of urinary bladder neck contracture
- •No prior allergy to latex
- •No Anesthesia Surgical Assignment category IV or greater
- •No interest in future fertility
- •No history of inflammatory bowel disease
- •No other concurrent major debilitating illness
- •No other prior or concurrent malignancy except skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior biologic therapy for prostate cancer
- •Chemotherapy:
- •No prior chemotherapy for prostate cancer
- •Endocrine therapy:
- •At least 3 months since prior hormonal therapy (including finasteride) for prostate cancer
- •Radiotherapy:
- •No prior radiotherapy for prostate cancer
- •No prior transurethral resection of prostate
- •No prior urethral stent
- •No prior major rectal surgery
- •No prior cryotherapy for prostate cancer
- •No prior thermotherapy
- •No other prior therapy for prostate cancer
- •No concurrent warfarin or other anticoagulant
排除标准
- 未提供