Prostate Cancer Stereotactic Radiotherapy (ESKO)
Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
Primary purpose of the study is to develop a stereotactic radiation treatment (RT) to prostate cancer which minimizes treatment related toxicity. Movement of the prostate during a radiation therapy will be monitored by temporary implanted electromagnetic transmitter. This data will be used to define prostate marginals (PTV) for stereotactic treatment. Radiation toxicity to rectum will be reduced by using a rectum fixation during a treatment.
Study group I (20 patients) will be treated 39 x 2 Gy and study group II (20 patients) with 20 x 3 Gy fractionation schedules. With the data collected from these groups treatment marginals to prostate will be defined and used to treat group III (40 patients) with 5 x 7.25 Gy.
Second purpose of this study is to assess if Diffusion-weighted magnetic resonance imaging could be used to evaluate radiation treatment response in intermediate prostate cancer. Androgen deprivation therapy is not allowed in this study.
研究概览
详细说明
New local prostate cancer patients needing external radiotherapy are included into three radiation dose groups;
Group I will be treated normal dosing (39 x 2 Gy) and study group II with hypofractionated dosing (20 x 3 Gy) and group III extreme hypofractionated dosing. Primary goal is to develop safe and effective curative radiotherapy for these patients
Second aim is to study Diffusion-weighted magnetic resonance image (DW MRI) in radiation treatment response in intermediate prostate cancer.
Patients are followed by MRI, PSA, bone scans and quality of life questionaries.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Tampere、芬兰、33521
- Tampere University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Biopsy-proven prostate Cancer
One or two risk factors for intermediate prostate cancer:
- Gleason score 7
- T2b-T2c
- PSA 10-20 microg/l
- No need for androgen deprivation therapy
- Eligible fo MRI
- Radical radiotherapy
Exclusion Criteria:
- Locally advanced or metastatic prostate cancer
- Previous radiotherapy to pelvic reason
- Other severe disease
- Previous cancer within 5 years
- Severe urinary symptoms at the start of the study (over 20)
- Wide cavity after transurethral resection of prostate (TURP)
学习计划
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：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：Conventional fractionation
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 15/39 fractions.
DW-MRI at baseline, 3 months and 12 months.
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During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 15/39 fractions.
DW-MRI at baseline, 3 months and 12 months.
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实验性的：hypofractionated
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 10/20 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 10/20 fractions.
DW-MRI at baseline, 3 months and 12 months
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实验性的：Stereotactic fractionation
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 5/5 fractions.
DW-MRI at baseline, 3 months and 12 months.
|
During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector.
Rectum fixation at 5/5 fractions.
DW-MRI at baseline, 3 months and 12 months
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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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To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
大体时间：1 to 3 months
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Prostate specific antigen (PSA) recurrence
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1 to 3 months
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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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Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy
大体时间：0 - 12 months
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PSA recurrence
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0 - 12 months
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quality of life changes
大体时间：1 to 3 months
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questionaires
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1 to 3 months
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合作者和调查者
调查人员
- 首席研究员：Petri Reinikainen、Tampere Unviersity Hospital
出版物和有用的链接
一般刊物
- Vanhanen A, Reinikainen P, Kapanen M. Radiation-induced prostate swelling during SBRT of the prostate. Acta Oncol. 2022 Jun;61(6):698-704. doi: 10.1080/0284186X.2022.2062682. Epub 2022 Apr 17.
- Vanhanen A, Poulsen P, Kapanen M. Dosimetric effect of intrafraction motion and different localization strategies in prostate SBRT. Phys Med. 2020 Jun 12;75:58-68. doi: 10.1016/j.ejmp.2020.06.010. Online ahead of print.
- Vanhanen A, Syren H, Kapanen M. Localization accuracy of two electromagnetic tracking systems in prostate cancer radiotherapy: A comparison with fiducial marker based kilovoltage imaging. Phys Med. 2018 Dec;56:10-18. doi: 10.1016/j.ejmp.2018.11.007. Epub 2018 Nov 16.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
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
与本研究相关的术语
关键字
其他研究编号
- ETL R14009
- R14009 (其他标识符：TampereUH)
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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