Development of Prostate Cancer Stereotactic Radiotherapy in Tampere Using Intra-fractional Movement Detector and Diffusion-weighted Magnetic Resonance Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven prostate Cancer
- •One or two risk factors for intermediate prostate cancer:
- •Gleason score 7
- •PSA 10-20 microg/l
- •No need for androgen deprivation therapy
- •Eligible fo MRI
- •Radical radiotherapy
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: stereotactic fractionation (Radiation)
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.
干预措施: Fractionation (Radiation)
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.
干预措施: hypofractionated (Radiation)
结局指标
主要结局
To determine whether the temporary implanted electromagnetic transmitter could be used to reduce treatment marginals in prostate cancer radiation therapy
时间窗: 1 to 3 months
Prostate specific antigen (PSA) recurrence
次要结局
- quality of life changes(1 to 3 months)
- Evaluation of DW-MRI to predict the outcome of prostate cancer radiation therapy(0 - 12 months)