ACTRN12617000035325招募中1 期
Phase I feasibility trial of stereotactic re-irradiation of prostate cancer recurrence within the definitively irradiated prostate
orthern Sydney Local Health District-Royal North Shore Hospital0 个研究点目标入组 36 人开始时间: 2017年1月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
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
- •1. Men > 4 years (yrs) from previous radiotherapy (RT) meeting the Phoenix definition of biochemical failure or men > 5yrs from RT if neo-adjuvant and/or adjuvant ADT also used
- •2. Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a)
- •3. Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region.
- •4. Life expectancy at least 10yrs from time of SBRT
- •5.PSA < 15 (within 2 months prior to enrolment)
排除标准
- •1 Recurrence in immediate proximity to rectum (unless able to have hydrogel)
- •2 Grade 3 or more toxicity from previous EBRT
- •3 Contra-indicated for fiducial markers insertion
- •4 GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)
研究者
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