Radiation Treatment of the Prostate That is Specially Adjusted for Each Person
2026年9月1日 更新者：AHS Cancer Control Alberta
DOSE ADAPTED PERSONALIZED ABLATIVE RADIOTHERAPY OF THE PROSTATE
A number of recent studies have successfully reduced the number of radiotherapy treatments used for prostate cancer from 39 daily treatments to as little as 5 treatments. This study is designed to determine how tumors inside the prostate respond during these 5 treatments on magnetic resonance imaging (MRI) and use that information to design 2 fraction radiotherapy treatments for prostate cancer.
For these two fraction treatments, the first fraction of radiation will use extra radiation to any nodules in the prostate, and the second fraction of radiation will give extra radiation to the nodule(s) in the prostate based on how those nodules responded to the first fraction of radiation. This idea is a relatively old concept but has not been used in the treatment of cancer yet. This research includes a clinical trial that evaluates whether it is safe to design treatments like this.
研究概览
研究类型
介入性
注册 (估计的)
50
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Charlie Kirkby
- 电话号码：403-388-6872
- 邮箱：Charles.Kirkby@cancercarealberta.ca
研究联系人备份
- 姓名：Asongna Folefoc
- 邮箱：Asongna.Folefoc@cancercarealberta.ca
学习地点
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Alberta
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Lethbridge、Alberta、加拿大、T1J 3H5
- 招聘中
- Jack Ady Cancer Centre
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接触：
- Charlie Kirkby
- 电话号码：403-388-6872
- 邮箱：Charles.Kirkby@cancercarealberta.ca
-
接触：
- Kevin Martell
- 邮箱：Kevin.Martell@CancerCareAlberta.ca
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- NCCN risk grouping of intermediate or high risk prostate cancer
- Patients must be 18 years of age, or older on the day of signing informed consent and be willing and able to provide written informed consent/assent
- Identifiable lesion within the epithelium of the prostate as determined by the treating radiation oncologist
- Have a prostate imaging reporting and data system (PIRADS) 4 or 5 nodule noted on MRI
- Have not received prior pelvic radiotherapy
- Life expectancy greater than 10 years
- ECOG performance status <3
- Eligible for SBRT to the prostate
Exclusion Criteria:
- No identifiable lesion within the prostate on 3T MRI
- Prior trans-urethral resection of the prostate
- Non-adenocarcinoma histology
- Meeting criteria for very high-risk risk or node positive prostate cancer
- Active inflammatory bowel disease
- Evidence of metastatic disease on CT or bone scan
- Declined radiotherapy
- Unlikely to be available for all follow-up appointments
- Having received androgen deprivation therapy or 5-alpha reductase therapy prior to trial therapy
- Extensive disease in the posterior prostate or aberrant anatomy that makes the safe delivery of boost irradiation not feasible
- Unable to understand or sign a study consent form after use of interpreter if required
- Has a relative contraindication to radiotherapy including systemic lupus erythematosus, TNM deficiency or scleroderma
- Unable to tolerate or ineligible for mpMR imaging
- Any condition or diagnosis, that could in the opinion of the treating physician or qualified investigator interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Arm 1/Stage 1: 5 weeks
The first group of 25 patients enrolled will receive 5 fractions of radiotherapy to their prostate with or without radiotherapy to their pelvic lymph nodes and an MRI midway through the treatment to assess the response of disease.
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External beam radiotherapy via stereotactic body radiotherapy (SBRT).
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实验性的：Arm 2/Stage 2: 3 weeks
The second group of 25 patients enrolled in this study will receive a single fraction of radiation to the prostate +/- pelvis with extra radiation to any nodule(s)/tumors in the prostate identified on MR.
They will then have a second MR after 3 weeks and based on that MR a second fraction of radiation to the prostate +/- pelvis will be delivered.
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External beam radiotherapy via stereotactic body radiotherapy (SBRT).
|
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 |
|---|---|---|
|
Incidence
大体时间：Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years
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Cumulative incidence of acute common terminology criteria for adverse events (CTCAE) v6.0 ≥ grade 2 genitourinary (GU) toxicity
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Baseline 3 weeks (includes treatment period for Arm 1 and 2) 1 month (includes treatment period for Arm 1) 3 months 6 months 2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence
大体时间：Baseline 3 weeks 1 month 3 months 6 months 2 years
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Cumulative incidence of acute CTCAE v6.0 ≥ grade 2 gastrointestinal (GI) toxicity
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Baseline 3 weeks 1 month 3 months 6 months 2 years
|
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Incidence
大体时间：2 years
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Cumulative incidence of CTCAE v6.0 ≥ grade 2 GU toxicity at 2 years
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2 years
|
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Incidence
大体时间：2 years
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Cumulative incidence of CTCAE v6.0 ≥ grade 2 GI toxicity at 2 years
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2 years
|
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international index of erectile function (IIEF-5)
大体时间：Baseline 3 weeks 1 month 3 months 6 months 2 years
|
IIEF-5 is a 5-item questionnaire (with a 1- 5 score for each item, 1 being the lowest or worst and 5 the highest/best) used to diagnose erectile disfunction.
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Baseline 3 weeks 1 month 3 months 6 months 2 years
|
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expanded prostate cancer index composite (EPIC)
大体时间：1 month and 2 years post treatment
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EPIC is a questionnaire designed to measure Quality of Life issues in patients with Prostate cancer.
Overall GU domain is scored from 1 to 5 with 1 being "No problem" and 5 being "Big problem"
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1 month and 2 years post treatment
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EPIC GI
大体时间：1 month and 2 years post treatment
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EPIC GI is about bowel habits and abdominal pain and has an overall score of1 - 5 with 1 being "No problem" and 5 being "Big problem"
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1 month and 2 years post treatment
|
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PSA
大体时间：2 years post treatment
|
Proportion of patients with PSA <0.4ng/mL at 2 years post treatment
|
2 years post treatment
|
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PSA nadir
大体时间：2 years post treatment
|
Absolute PSA nadir at 2 years post treatment (all therapy)
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2 years post treatment
|
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MRI
大体时间：treatment week 3
|
MRI based radiographic response of DIL at on treatment week 3
|
treatment week 3
|
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MRI response
大体时间：6 months post treatment
|
MRI based radiographic response at 6 months post treatment
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6 months post treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月26日
初级完成 (估计的)
2031年6月1日
研究完成 (估计的)
2032年6月1日
研究注册日期
首次提交
2026年5月1日
首先提交符合 QC 标准的
2026年5月6日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.