ACTRN12607000097448已完成3 期
Trans Tasman Radiation Oncology Group (TROG) 03.04 - A randomised trial investigating the effect on biomedical (Prostate Specific Antigen- PSA) control and survival of different durations of adjuvant androgen (Leuprorelin acetate and zoledronic acid)deprivation in association with definite radiation treatment for localised carcinoma of the prostate (The RADAR trial)
Trans Tasman Radiation Oncology Group (TROG)0 个研究点目标入组 1,000 人开始时间: 2003年12月23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
- 1,000
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
- •Histological confirmation of adenocarcinoma of the prostate in the three months prior to randomisation- Gleason primary and secondary pattern reported. If the volume of tumour in biopsies is too small for the pathologist to allocate a secondary pattern, the primary pattern alone is sufficient.- Primary tumour stage T2b - 4 (UICC 2002), or T2a providing biopsies demonstrate Gleason score 7 or more, and presenting PSA 10 or more- PSA value obtained within one month of randomisation- No evidence of lymphatic or haematogenous metastases, as determined by negative chest x-ray, CT scan of abdomen and pelvis, and bone scan in the 3 months prior to randomisation- ECOG performance status 0 - 1- No concurrent medical conditions likely to significantly reduce prospects of 5 year survival- Patient accessible to follow up at intervals specified in protocol- Written informed consent given (signed by both patient and investigator prior to randomisation)
排除标准
- •Previous or concurrent malignancy within previous 5 years except for non-melanomatous skin cancer- Prostatectomy- Prior pelvic radiotherapy- Prior hormone treatment for prostate cancer- Inability to complete self administered QOL questionnaire- Prior bisphosphonate therapy- Serum creatinine > 2 x ULN- Osteoporosis resulting in >30% loss in vertebral height in one or more thoraco-lumbar vertebrae- Liver disease resulting in ALT or AST levels >3 x ULN- Prolonged continuous glucocorticoid therapy > 10 mg/day of prednisone equivalent (>6 months)- Current treatment with bisphosphonate
研究者
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