ISRCTN45905321已完成3 期

Hypofractionated radiotherapy of intermediate risk localised prostate cancer: a phase III, randomised, open, multicentre trial

County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)0 个研究点目标入组 1,200 人开始时间: 2009年2月10日最近更新: 2021年1月25日

适应症

试验速览

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31227373 (added 24/06/2019) 2021 quality of life results in https://pubmed.ncbi.nlm.nih.gov/33444529/ (added 15/01/2021)

•1. Men less than 75 years of age and, as judged by the doctor, a life expectancy of 10 years (except for cancer) at time of randomisation with performance status World Health Organization (WHO) grades 0 - 2
•2. Patients with a histologically verified prostatic cancer
•3. Patients with intermediate risk prostatic cancer of clinical category T1c - T3a with one or two of the following risk factors:
•3.1. T3a or Gleason greater than 7
•3.2. PSA greater than 10 according to the TNM classification system UICC 2002
•4. PSA less than 20 µg/L
•5. The patients should have no evidence of metastases according to the definition above
•6. Patients should be lymph node negative according to the definition above, i.e. staging
•7. Patients should be suitable for radiotherapy
•8. Patients must have signed informed consent

•1. Patients who earlier have undergone any other treatment for prostatic cancer
•2. Patients unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis)
•3. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour.
•4. Previous hormone therapy (castration or anti-androgens)
•5. Any condition that prevent markers implantation, i.e. anal fissure

发起方

County Council of Västerbotten (Västerbottens läns landsting [VLL]) (Sweden)