Phase I Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
研究概览
简要总结
This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores
- •Radical Prostatectomy (RP) chosen as the therapeutic method
- •The size of the prostate will be < 70 cc by transrectal ultrasound or endorectal MRI imaging
- •No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease
- •Risk of extraprostatic cancer of > 40% based on the MSKCC surgical nomogram
- •Age > or = to 18 years
- •KPS > or = to 80
- •Able to tolerate immobilization cradle positioning
排除标准
- •Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded)
- •Prior radiation to the planned target region
- •Patients receiving concurrent chemotherapy
- •Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen)
- •Prior transurethral resection of the prostate
- •Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints
- •Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies
- •Creatinine clearance <60 ml/min/1.73m2
研究组 & 干预措施
High-Dose Single-Fraction Image-Guided Radiotherapy
This will assess the feasibility and safety of this approach in men at high-risk for extraprostatic prostate cancer undergoing RP. This initial trial has been designed in a manner intended to emphasize patient comfort and safety.
干预措施: High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy (Radiation)
结局指标
主要结局
To assess the feasibility and safety of single-fraction image-guided intensity modulated radiotherapy (IG-IMRT).
时间窗: 1 year
Given prior to radical prostatectomy (RP) in men at high risk for extraprostatic cancer.
次要结局
- To assess the long-term toxicity of intensity modulated radiotherapy (IG-IMRT)(weeks 3, 6, 9, 12, 18, 24, 30, and 36 months after RP)
- To analyze the changes in prostate perfusion induced by single-fraction IG-IMRT.(1 before radiation simulation, 1 after radiation treatment)
- To assess the effect of IG-IMRT on the anticipated positive margin rate at the time of RP.(1 year)