Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
研究概览
简要总结
Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.
详细描述
IGRT-schedule: 20 fractions to a total dose of 60 Gy
Personalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).
Treatment at MR-Linac allowed
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •biopsy-proven prostate cancer with indication for RT
- •cT1b-cT3a cN0 cM0
- •ECOG Performance score 0-2
- •IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
- •age>18 years
- •Informed consent
排除标准
- •not fulfilled inclusion criteria
- •contraindication against curative RT
- •age<18 years
- •previous pelvic radiotherapy or planned pelvic radiotherapy
- •comorbidities interfering with image-guided radiotherapy
- •contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)
- •prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate
研究组 & 干预措施
Hypofractionated image-guided radiotherapy
Hypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed.
Weekly MRI are used to estimate volume/deformation changes of OAR and target volume.
Intervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy.
干预措施: Plan adaptation of Radiation Treatment in case of anatomical changes (Radiation)
结局指标
主要结局
Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
时间窗: 2 years
Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%
次要结局
- Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT(6 months)
- Rate of participants achieving local control(2, 5, 10 years)
- Number of Participants with biochemical no evidence of disease "bNED"(2, 5, 10 years)
- Progression-free survival "PFS"(2, 5, 10 years)
- Rate of participants achieving regional control(2, 5, 10 years)
- Rate of participants achieving Distant-metastasis-free survival "DMFS"(2, 5, 10 years)
- CTC-Proctitis(2, 5, 10 years)
- Overall survival "OS"(2, 5, 10 years)
- Time without secondary treatment "TWIST"(2, 5, 10 years)
- CTC-Incontinence(2, 5, 10 years)
研究者
Arndt-Christian Mueller
Deputy Head of the Department of Radiation Oncology
University Hospital Tuebingen