Whole Versus Partial Gland Boost During Prostate SBRT
Whole Versus Partial Gland Boost During Prostate SBRT (Gland Boost)
研究概览
地位
详细说明
This is a phase 2/3 randomized clinical trial evaluating two dose escalation strategies during prostate stereotactic body radiotherapy (SBRT). A total of 186 patients with prostate adenocarcinoma will be enrolled and randomized in a 1:1 ratio to one of two treatment arms.
In both arms, patients will receive 3625 cGy delivered to the planning target volume (PTV) over 5 fractions. In Arm A, patients will receive a boost to the prostate gland. In Arm B, patients will receive a boost to the dominant intra-prostatic lesion (DIL) identified on pre-treatment magnetic resonance imaging (MRI).
The primary objective is to evaluate chronic genitourinary (GU) and gastrointestinal (GI) toxicities grade 2 or higher from 6 months to 2 years post-treatment using the Common Terminology Criteria for Adverse Events (CTCAE). Secondary objectives include evaluation of acute and chronic GU and GI toxicities using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains, as well as biochemical progression-free survival at 5 years.
Participants will be followed for up to 5 years after completion of treatment.
研究类型
注册 (估计的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Krishna Gottipati, MS
- 电话号码：4025593518
- 邮箱：krgottipati@unmc.edu
研究联系人备份
- 姓名：IIT Office Gottipati
- 电话号码：4025590963
- 邮箱：IITOFFICE@unmc.edu
学习地点
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Nebraska
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Omaha、Nebraska、美国、68198
- Fred & Pamela Buffet Cancer Center
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接触：
- Michael Baine, MD, PhD
- 电话号码：(402) 552-2703
- 邮箱：mbaine@unmc.edu
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Adults ≥19 years of age
- Patients with a diagnosis of prostate adenocarcinoma for which stereotactic body radiotherapy (SBRT) to the prostate ± proximal seminal vesicles is being offered
- Prostate gland volume <100 cc prior to initiation of androgen deprivation therapy (ADT), as reported at time of biopsy or by imaging (e.g., ultrasound, MRI, or CT)
- PI-RADS 4 or 5 lesion seen on pre-treatment MRI
- IPSS/AUA symptom score less than 16
Exclusion Criteria:
- Prior treatment for prostate cancer
- Prior solid cancer diagnosis within the last 5 years
- Any history of anal or rectal cancer
- Any history of invasive carcinoma of the bladder
- History of prior circumferential resection of the rectum (such as LAR or APR)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Arm A: boost to prostate alone
Participants assigned to Arm A will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4000 cGy to the clinical target volume (CTV), consisting of the prostate alone without a margin.
Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
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External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost
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实验性的：Arm B: boost to dominant intra-prostatic lesion (DIL)
Participants assigned to Arm B will receive external beam radiation therapy consisting of 3625 cGy to the planning target volume (PTV), plus a boost of 4500 cGy to the dominant intra-prostatic lesion (DIL).
Treatment will be delivered over 5 fractions with at least 36 hours between fractions via simultaneous integrated boost (SIB).
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External beam radiation therapy delivered via linear accelerator-based SBRT using simultaneous integrated boost to the dominant intra-prostatic lesion.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Grade 2 or Higher Chronic Genitourinary Toxicity
大体时间：From 6 months post-treatment to 2 years post-treatment
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Cumulative incidence of grade 2 or higher chronic genitourinary (GU) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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From 6 months post-treatment to 2 years post-treatment
|
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Grade 2 or Higher Chronic Gastrointestinal Toxicity
大体时间：From 6 months post-treatment to 2 years post-treatment
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Cumulative incidence of grade 2 or higher chronic gastrointestinal (GI) toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
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From 6 months post-treatment to 2 years post-treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Biochemical Progression-Free Survival
大体时间：From initiation of study treatment to 5 years post-treatment
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Time from initiation of study treatment to biochemical disease progression or death from any cause.
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From initiation of study treatment to 5 years post-treatment
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Acute Gastrointestinal Toxicity
大体时间：From end of treatment to 6 months post-treatment
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Cumulative incidence of acute gastrointestinal (GI) toxicities assessed using CTCAE, Radiation Therapy Oncology Group (RTOG), and Expanded Prostate Cancer Index Composite (EPIC) domains.
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From end of treatment to 6 months post-treatment
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Acute Genitourinary Toxicity
大体时间：From end of treatment to 6 months post-treatment
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Cumulative incidence of acute genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
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From end of treatment to 6 months post-treatment
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Chronic Gastrointestinal Toxicity
大体时间：From 6 months post-treatment to 5 years post-treatment
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Incidence of chronic gastrointestinal (GI) toxicities assessed using CTCAE, RTOG, and EPIC domains.
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From 6 months post-treatment to 5 years post-treatment
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Chronic Genitourinary Toxicity
大体时间：From 6 months post-treatment to 5 years post-treatment
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Incidence of chronic genitourinary (GU) toxicities assessed using CTCAE, RTOG, and EPIC domains.
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From 6 months post-treatment to 5 years post-treatment
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合作者和调查者
调查人员
- 首席研究员：Michael Baine, MD, PhD、University of Nebraska medicine
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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