ISRCTN04483921进行中(未招募)2 期
Dose EscaLation to Intraprostatic tumour Nodules in localisEd prostATE cancer: A phase II study examining the toxicity and feasibility of a dose escalated boost to a magnetic resonance imaging identified tumour nodule or nodules in localised prostate cancer
Institute for Cancer Research (UK)0 个研究点目标入组 265 人开始时间: 2011年8月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 265
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36150450/ (added 29/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Age more than or equal to 18 years
- •2. Histologically confirmed adenocarcinoma of the prostate
- •3. National Collaborative Cancer Network+ (NCCN) risk groups intermediate or high risk localised prostate cancer
- •4. Normal blood count [haemoglobin (Hb) > 11g/dl, white blood cell (WBC) > 4000/mm³, platelets > 100,000/mm³]
- •5. World Health Organisation (WHO) performance status 0 or 1
- •6. Life expectancy of 10 years or more
- •7. Written informed consent
- •8. Patients must be prepared to attend follow-up
- •9. For template biopsy sub-study must be considered fit for general / spinal anaesthetic; Target Gender: Male ; Lower Age Limit 18 no age limit or unit specified
排除标准
- •1. Prior radiotherapy to the prostate or pelvis
- •2. Bilateral hip replacement
- •3. Prior hormone therapy
- •4. Radical prostatectomy
- •5. Lymph Node Risk > 30%
- •6. National Collaborative Cancer Network+ (NCCN) Favourable Risk Group
- •7. Evidence of seminal vesicle invasion, nodal or metastatic disease
- •8. Any previous invasive cancer in the past 5 years, with the exception of non-melanoma skin cancer
- •9. Patients with medical contraindication to magnetic resonance imaging (MRI) scanning
研究者
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