ISRCTN85138529已完成3 期
HYpofractionated irradiation for PROstate cancer: a randomised multicentre phase III study
Erasmus Medical Center (The Netherlands)0 个研究点目标入组 800 人开始时间: 2006年11月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 800
研究概览
简要总结
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/25656287 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27339116 2020 results in https://www.ncbi.nlm.nih.gov/pubmed/31593756 (added 14/02/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •1. Histologically proven adenocarcinoma of the prostate
- •2. Intermediate or high risk prostate cancer:
- •2.1. Low risk:T1-2a and Prostate Specific Antigen [PSA] less than 10 µg/L and Gleason score less than or equal to six
- •2.2. Intermediate risk: Not low risk or high risk
- •2.3. High risk: One or more of the following high risk factors: T3-4, PSA more than 20 µg/L, Gleason score more than or equal to eight)
- •3. The administration of concomitant hormonal therapy is allowed
- •4. World Health Organisation (WHO) performance status zero to two
- •5. Written informed consent
- •6. Willing to fill out the quality of life questionnaires
排除标准
- •1. Pretreatment PSA more than or equal to 60 µg/l
- •2. Previous irradiation in the pelvic region or radical prostatectomy
- •3. Radiological evidence of pelvic nodal disease (computed tomography [CT] pelvis)
- •4. Presence of distant metastasis (bone scintigraphy)
- •5. Patients candidates for elective lymph node irradiation
- •6. Low-risk prostate cancer (T1-2a and PSA less than 10 µg/L and Gleason score less than or equal to six)
研究者
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