ACTRN12620000463976招募中4 期
A prospective, open-label, multi-centre, registry-based randomised clinical trial comparing the cognitive impact of standard-of-care treatments in men aged 75 years or older that have metastatic castration-resistant prostate cancer.
Walter and Eliza Hall Institute for Medical Research0 个研究点目标入组 200 人开始时间: 2020年4月9日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
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
- 75 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Age greater than or equal to 75 years
- •Diagnosis of metastatic castration-resistant prostate carcinoma
- •Eligible for PBS-subsidised therapy with abiraterone or enzalutamide
- •Suitable to receive full dose therapy
- •Able to take oral medications
- •Able to complete telephone interviews
排除标准
- •Previous systemic therapy for CRPC other than docetaxel.
- •Contraindication to abiraterone therapy include but are not limited to:
- •Uncontrolled hypertension.
- •Clinically significant ischemic heart disease or congestive cardiac failure
- •Significant hepatic dysfunction including chronic liver disease or active viral hepatitis; ALT or AST greater than or equal to 2.5 times upper limit of normal range or greater than or equal to 5 times upper limit of normal in presence of liver metastases.
- •Pituitary or adrenal dysfunction.
- •Contraindication to corticosteroids.
- •Contraindication to enzalutamide therapy include but are not limited to:
- •Previous seizures or a condition that confers a predisposition to seizures.
- •History of clinically significant neuropsychiatric event.
- •Clinically significant cognitive impairment.
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