MRI Substudy; Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Change in hepatic fat content
研究概览
简要总结
The purpose of this study is to investigate if androgen deprivation therapy in men with prostate cancer increases hepatic fat content and changes visceral/subcutaneous fat distribution.
详细描述
This is a substudy of the ongoing randomized trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29). 20 consecutive patients are anticipated to participate regardless of assignment to either orchiectomy or triptorelin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligible for inclusion are patients who are included in the already ongoing Randomised trial entitled: Metabolic Changes Due to Iatrogenic Hypogonadism in Patients With Prostate Cancer: Orchiectomy vs. Triptorelin (EudraCT number: 2013-002553-29)
排除标准
- •Implanted devices or foreign metallic bodies incompatible with Magnetic Resonance Imaging.
- •claustrophobia
- •Severe Psychiatric disease
研究组 & 干预措施
Triptorelin
Triptorelin 22,5mg/24th week intramuscularly
干预措施: Triptorelin (Drug)
orchiectomy
Androgen deprivation therapy by bilateral subcapsular orchiectomy
干预措施: Orchiectomy (Procedure)
结局指标
主要结局
Change in hepatic fat content
时间窗: At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks
Change in hepatic fat content measured by Magnetic Resonance Spectroscopy
次要结局
- Change in visceral/subcutaneous fat mass(At baseline (within 4 weeks of commencement of androgen deprivation therapy) and after 24 weeks)
- Correlation between Hepatic fat content and baseline androgen status(Androgen status measured before commencement of androgen deprivation therapy (ADT), hepatic fat content measured at baseline (within 1 month of commencing androgen deprivation therapy))