NCT05364229进行中（未招募）不适用
MR-guided Tumour Boost With Stereotactic Body Radiotherapy in Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost
研究概览
简要总结
This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.
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
- 否
入选标准
- •Histologically-proven localized prostate cancer.
- •Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor)
- •Low-risk: cT1-T2a, PSA <10, and Gleason score 6
- •Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7
- •High-risk limited to 1 risk factor: >T2, PSA >20, or Gleason score >7
- •Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/< 1/3 total prostate volume
- •Planned for EBRT (+/- ADT)
- •ECOG 0 or 1
- •18 years of age or older
- •Ability to provide written informed consent to participate in the study
排除标准
- •Prior radiotherapy to pelvis
- •Radiological evidence of regional or distant metastases at the discretion of the treating physician.
- •Active ulcerative colitis or Crohn's Disease, at discretion of treating physician
- •Ataxia Telangectasia and SLE
- •Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury
- •Severe claustrophobia
研究组 & 干预措施
MR-guided Tumour Boost with SBRT
Experimental
MR-guided radiotherapy boost to MRI visible tumour
干预措施: MR-guided Radiotherapy Boost (Radiation)
结局指标
主要结局
Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost
时间窗: Baseline
Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75
次要结局
- Patient-reported quality-of-life assessed by EPIC-26(Baseline to 5-year follow-up)
- Acute Toxicity(Baseline to 5-year follow-up)
- Late Toxicity(Baseline to 5-year follow-up)
研究者
研究点 (1)
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