NCT00318240已完成不适用
Feasibility Study for Locally Recurrent Prostate Cancer Treatment Following Radiation Failure With High Intensity Focused Ultrasound (HIFU)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.
研究概览
简要总结
This is a feasibility study to determine safety and the ability of HIFU (High Intensity Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local recurrence of prostate cancer following radiation treatment.
详细描述
This is a feasibility study to determine the safety and the ability of HIFU (High Intensity Focused Ultrasound)to selectively destroy prostate cancer tissue in men who demonstrate local recurrence of prostate cancer following radiation treatment. All participants will receive treatment with HIFU and be monitored closely for recurrence of disease (if any),quality of life and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •· Male patients with an initial presentation of organ confined recurrent prostate cancer (clinical Stages T1 and T2 only) who have been treated with external beam radiation therapy or brachytherapy and subsequently has biopsy-proven local recurrence.
- •Age > 40 years through <80 years.
- •Anesthesia Surgical Assignment (ASA) categories I, II or III only.
- •Negative radionuclide bone scan within 3 months prior to HIFU treatment to rule out the possibility of metastases.
- •PSA levels >0.5ng/ml and <10ng/ml.
- •Pre-radiation Gleason score < 8
- •Clearly imageable prostate on TRUS
- •Written informed consent.
排除标准
- •· T3 or T4 prostate cancer.
- •Age <40 years. or >80 years.
- •ASA of IV and higher.
- •Gleason score>
- •PSA <0.5ng/ml or >10ng/ml.
- •Prostate size > 40 grams as determined by transrectal ultrasound
- •Large calcification in the area to be treated (>5mm).
- •Bleeding disorder as determined by abnormal prothrombin time (INR)and partial thromboplastin time (PTT).
- •Patient on Coumadin or any other anticoagulant, unless their anticoagulation can be temporarily reversed or stopped.
- •Urinary tract infection unless treated satisfactorily by antibiotics and documented by a sterile urine culture.
- •Interest in future fertility.
- •History of allergy to latex.
- •Inability to visualize the prostatic tissue adequately on transrectal ultrasound imaging.
- •Currently on hormonal therapy for prostate cancer (patients can be enrolled if they come off hormone therapy for 3 months).
- •History of treatment for prostate cancer, other than brachytherapy or external beam radiation.
- •History of TURP, thermotherapy or urethral stent.
- •History of any major rectal surgery.
- •History of inflammatory bowel disease.
- •History of urinary bladder neck contracture.
- •History of any other malignancy other than skin cancer.
研究组 & 干预措施
1
Experimental
High Intensity Focused
干预措施: High Intensity Focused Ultrasound (Device)
结局指标
主要结局
To determine the efficacy of HIFU in men with local recurrent prostate cancer following radiation therapy.
时间窗: ongoing
次要结局
- Destruction of prostate cancer tissue.(ongoing)
- Safety of repeating procedure in patients who do not respond adequately.(ongoing)
研究者
研究点 (2)
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