Use of Rectal Spacers in Prostate Cancer Patients Undergoing Radiation Therapy: a Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Dosimetry
研究概览
简要总结
This is a prospective clinical study involving up to 150 subjects with localized prostate cancer who are scheduled for radiation treatment with rectal spacer placement.
The goal of this clinical trial is to assess the safety and efficacy of perirectal spacers in patients undergoing radiation therapy for the treatment of localized prostate cancer.
Study visits:
- Screening
- Spacer placement
- Treatment planning simulation
- End of the radiation treatment
- 1, 3, 6, 12, 18 and 24-months FU visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Patients with prostate cancer ≥ 18 years of age.
- •Patients are in one of the following risk groups:
- •T1-T3 prostate cancer with no posterior extra capsular extension
- •Gleason score ≤ 7
- •Planned for radiation treatment with rectal spacer.
- •Ability to understand and the willingness to sign a written informed consent form.
排除标准
- •Metastatic disease.
- •Previously treated localized adenocarcinoma of the prostate.
- •Active Inflammatory bowel disease requiring treatment with steroids.
- •Prior total prostatectomy.
- •Current urinary tract infection.
- •Acute or chronic prostatitis.
研究组 & 干预措施
BioProtect Balloon Implant System
The Bio Protect Balloon Implant System (BioProtectLtd.,TzurYigal,Israel) is an Food and Drug Administration approved rectal spacer that consists of a solid biodegradable balloon-shaped material composed of poly L-Lactide-co-caprolactone
干预措施: BioProtect Balloon Implant™ System (Device)
结局指标
主要结局
Dosimetry
时间窗: 6 months
Dose-volume histogram (DVH) including the percent of the rectal volume receiving 70 Gy
次要结局
未报告次要终点
研究者
Shawn Zimberg, MD
Dr Shawn Zimberg, Radiation Oncology Medical Director, Radiation Oncology
Advanced Radiation Centers of New York