Pilot Study of High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity.
研究概览
简要总结
High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR brachytherapy gives precise radiation to the prostate with less radiation given to the normal tissues near the prostate. For patients who have been treated with external beam radiation to the prostate before, HDR brachytherapy can give radiation again to the prostate without exposing the normal tissues around the prostate to significantly more radiation. This may be safer than giving external beam radiation again. The purpose of this study is to test the safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back after external beam radiation. We want to find out what effects, good and/or bad, the treatment has on you and your recurrent prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •KPS > than or equal to 80
- •Able to give informed consent
- •Able to complete toxicity scales and questionnaires
- •Histologically MSKCC confirmed diagnosis of recurrent prostate cancer.
- •Documented history of definitive radiotherapy to the prostate gland
- •IPSS of < than or equal to 15 at the time of evaluation
- •PSA < than or equal to 15 ng/ml
- •Organ confined disease
排除标准
- •Unable to tolerate general anesthesia
- •Abnormal complete blood count. Any of the following:
- •Platelet count less than 75,000/ml
- •Hb level less than 10 gm/dl
- •WBC less than 3.5/ml
- •Abnormal coagulation profile:
- •INR > 2.5
- •Abnormal Liver function tests (>1.5 x normal value)
- •Abnormal renal function tests (creatinine > 1.5)
- •Evidence of metastatic disease (bone scan, radiographs, MRI findings)
- •Prostate volume > 50 cc
- •Unable to meet treatment planning criteria
- •History of rectal surgery
- •External beam radiation dose to the prostate > 86.4 Gy if standard treatment planning dose constraints were met
- •History of inflammatory bowel disease
- •Expected survival < 1 year
- •Unable to undergo bone scan, CT or MRI evaluation
- •Unavailable for regular follow up
结局指标
主要结局
assess feasibility & toxicity of HDR as salvage ther for local recurrent prostate cancer after ext beam radiotherapy. QOL instruments and questionnaires including the MSK prostate QOL instrument, the IIEF, IPSS , & the NCI CTC is used to assess toxicity.
时间窗: conclusion of study
次要结局
- To assess biochemical or PSA relapse free survival.(conclusion of study)