Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction of Lower Urinary Tract Symptoms
研究概览
简要总结
This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.
详细描述
PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.
Advanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.
In addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.
Therefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Curative treatment of PCA intended
- •Contraindications for MRI
- •Renal impairment (GFR < 30ml/min)
- •Allergy to i.v. contrast medium
- •Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels)
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- •Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE.
结局指标
主要结局
Reduction of Lower Urinary Tract Symptoms
时间窗: Baseline and 12 weeks
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
次要结局
- Occurrence of urinary incontinence(12 months after PAE)
- Estimation of tumor volume(Baseline and 12 weeks after PAE)
- Reduction of Lower Urinary Tract Symptoms(Baseline and 12 months)
- Reduction of Prostate symptoms(baseline and 12 months)
- Changes of free urinary flow rate(Baseline and 12 months)
- Rate of local reinterventions(During 1 year study period)
- Estimation of tumor burden(Baseline and 12 months after PAE)
- Adverse Events(12 months after PAE)
- Occurrence of macroscopic hematuria(From time of PAE to study completion (1 year))
- Intraoperative Adverse Events(While PAE is performed (intra-operatively))
- Prostate volume(Baseline and 12 weeks after PAE)
- Changes of post void residual urine(Baseline and 12 months)
- Feasibility of PAE(While PAE is performed (intra-operatively))
研究者
Dominik Abt
Dr. med.
Cantonal Hospital of St. Gallen