NCT04100174招募中2 期
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
Centre hospitalier de l'Université de Montréal (CHUM)3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年7月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Urinary Quality of Life
研究概览
简要总结
To determine if fBT+sRT is superior to standard care in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL
详细描述
In this Phase IIR trial investigators primarily seek to determine if fBT boost (15Gy) to SBRT (35Gy/5) can be shown to be superior to standard care (whole-gland BT boost 15Gy to RT 37.5Gy/15) in terms of urinary toxicity by having fewer patients experience a minimal important decline (MID) in urinary irritation/obstructive QoL as measured by ePRO (EPIC-26) at 12 and 24 months post completion of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland.
- •Charlson Comorbidity Index ≤ 4
- •Imaging visible disease encompassing < 50% of the prostate gland and consistent with biopsy findings.
- •Exclusion - none
排除标准
- 未提供
结局指标
主要结局
Urinary Quality of Life
时间窗: 12-24 months
EPIC
次要结局
未报告次要终点
研究者
研究点 (3)
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