NCT06594887招募中不适用
Use of Rectal Spacers for Proton Beam Radiation Therapy for Localized Prostate Cancer: Prospective Clinical Study
Princeton ProCure management, LLC.2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Perirectal distance
研究概览
简要总结
This prospective, 2-arm clinical trial aims to evaluate the use of rectal spacers in patients with localized prostate cancer scheduled for Proton Beam Therapy (PBT). Up to 50 subjects will be enrolled in this study.
Study visits will include screening, spacer placement, treatment planning, end-of-treatment assessment, and follow-up visits at 1, 3, and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Subjects greater than 18 years old with prostate cancer
- •Subjects must have histologically confirmed adenocarcinoma of the prostate with biopsy taken within 12 months and must be planned to undergo proton beam therapy with rectal spacer
- •Subjects must have clinical stage T1-T3 with no posterior extra capsular extension of the prostate cancer
- •PSA less than or equal to 20 ng/mL
- •Gleason Score less than or equal to 7
- •Capacity to comprehend and readiness to sign a written informed consent form
排除标准
- •Planned Pelvic lymph node radiotherapy.
- •Metastatic disease.
- •Prior local prostate cancer therapy
- •Active Inflammatory bowel disease requiring treatment with steroids.
- •Prior radical prostatectomy.
- •Active urinary tract infection.
- •Acute or chronic inflammation or infection of the prostate.
结局指标
主要结局
Perirectal distance
时间窗: 2-4 months
Perirectal distance evaluated by measurement of the prostate-rectum separation as measured on treatment planning CT simulation.
次要结局
- Spacer stability over time(2-4 months)
- Mean rectal dose(2-4 months)
研究者
Edward M. Soffen, M.D.
Edward M. Soffen, M.D.
Princeton ProCure management, LLC.
研究点 (2)
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