ACTRN12623000919617尚未招募2 期
A clinical trial exploring MR guided adaptive stereotactic radiotherapy boost to the prostate combined with stereotactic radiotherapy to the whole pelvis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- GenesisCare
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1.Patient capable of giving informed consent
- •2.Histological diagnosis of prostate cancer
- •3.Intermediate or High-risk disease respectively defined by any one of:
- •a.Baseline Prostate Specific Antigen (PSA) 10-20, Gleason grade 7 disease, Clinical stage T2b-c OR
- •b.Baseline PSA equal to or more than 20, Gleason grade 8-10 disease, Clinical stage T3
- •4.For high-risk patients, conventional staging (in the form of any of the below) negative for extra pelvic disease:
- •a.PSMA PET scan OR
- •b.Tc99m whole body bone scan AND
- •c.Either CT of the abdomen and pelvis or MRI pelvis
- •5.No previous pelvic radiotherapy
排除标准
- •1.ECOG performance status more than 1
- •2.Inability to have an MRI due to:
- •a.Implanted magnetic metal eg intraocular metal
- •b.Pacemaker or Implantable defibrillator
- •c.Extreme claustrophobia
- •3.Clinical stage T4 (tumour invasion into adjacent anatomical structures)
- •4.Inflammatory bowel disease
- •5.Severe obstructive urinary symptoms
- •6.Inability to meet planning objectives
- •7.Severe Claustrophobia
- •8.Contraindication to MRI
研究者
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