ACTRN12619000097145招募中2 期
A phase II, open label study of durvalumab (medi4736) in combination with stereotactic body radiotherapy (sbrt) in androgen-intact patients with oligo metastatic prostate cancer measuring psa response
orthern Sydney Local Health District0 个研究点目标入组 30 人开始时间: 2019年1月23日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- •adenocarcinoma prostate treated definitively with either radiotherapy or surgery
- •disease free interval of > 24mths from definitive management
- •At least 5 half-lives since any agent causing androgen deprivation and current Testosterone of > 5nmol/L
- •PSMA scan within 4 weeks of enrolment
- •PSMA detected metastases either
- •a.1-3 and suitable for SBRT (Lymph node &/or bone)
- •b.>3 but confined to pelvis and paraaortic regions
排除标准
- •-•Any concurrent use of agents that reduce androgen production or block androgen action.
- •-•Active or prior documented significant autoimmune or inflammatory disorders
- •-•Current or prior use of immunosuppressive medication within 14 days before the first dose of study treatment.
研究者
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