ACTRN12614000858695终止2 期
A single arm, prospective Phase II study to evaluate the effect of Split-Course Pelvic Radiotherapy on bladder and bowel health related quality of life in patients with locally progressive, castrate resistant prostate cancer.
Radiation Oncology Services - Mater Centre0 个研究点目标入组 18 人开始时间: 2014年8月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
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
- Non-randomised 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
- •Aged 18 years or older
- •Has provided written Informed Consent for participation in this trial
- •Histological or cytologically confirmed prostate cancer or where diagnosis made on clinical factors, a PSA >100ug/L at diagnosis
- •Castrate resistant disease, as defined by a rising PSA despite castrate levels of testosterone <0.5 ug/L
- •Patient has symptoms attributable to local disease progression OR is asymptomatic with T3 or T4 disease but and felt to be at risk of symptomatic local progression (these patients to be included in analysis of secondary endpoints 1, 3 and 4)
- •An ECOG performance status score of 2 or less
- •Life expectancy at least 6 months
- •Available for follow up at least via a phone interview.
- •Radiotherapy can commence within 6 weeks of trial registration.
- •Is able to complete QOL assessments
排除标准
- •Previous radiotherapy to the pelvis
- •Bilateral hip replacement surgery
- •Cytotoxic chemotherapy within 4 weeks of the proposed start date for radiotherapy
- •Prior diagnosis of cancer within 5 years of current diagnosis with the exception of successfully treated non-melanoma skin cancer
研究者
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