Prostate Artery Embolization Safety and Efficacy: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
研究概览
简要总结
The purpose of this project is to evaluate the safety, efficacy, and feasibility of performing prostatic artery embolization (PAE) using endovascular techniques and particle embolics in men suffering from lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).
详细描述
This pilot study is a prospective, non-randomized clinical trial assessing the safety and feasibility of prostatic artery embolization. Fifty adult male subjects will be enrolled and treated in this study. Patients who provide informed consent and are deemed eligible for participation will undergo prostatic artery embolization in the Interventional Radiology department at the University of Virginia. After performing an angiogram to identify the prostatic arteries, tiny particles known as Embozene Microspheres will be injected into the prostatic artery. Injecting these particles into the prostatic artery will slow blood flow to the prostate and thus shrinking the size of the prostate. By shrinking the size of the prostate, it is hopeful that it will provide relief of lower urinary tract symptoms due to BPH. Subjects will be followed for 2 years as part of their participation in this 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
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients between ages 45-80 years
- •Diagnosis of Lower Urinary Tract Symptoms from Benign Prostatic Hypertrophy for a minimum of 6 months
- •IPSS score at initial evaluation should be greater than 7, and uroflowmetry (Qmax) of <12mL/s (milliliters per second) .
- •All prostate volumes will be at least 40gm and no more than 400gm based on DRE, TRUS, or cross sectional imaging
排除标准
- •Patients with urinary tract infections (> 2/year), prostatitis, or interstitial cystitis
- •Cases of biopsy proven prostate cancer or urethral cancer.
- •Patients on long-term narcotic analgesia, androgen therapy, or GNRH (gonadotropin-releasing hormone) analogue therapy within 2 months of study.
- •Patients who are classified as New York Heart Association Class III (Moderate), or higher.
- •Patients with history of prior pelvic irradiation.
- •Hypersensitivity reactions to contrast material not manageable with prophylaxis.
- •Patients with serum creatinine values >1.7mg/dl or glomerular filtration rates less than 50.
研究组 & 干预措施
Embozene Microspheres
Embozene Microspheres are spherical particles consisting of a hydrogel core and a poly nanocoat that will be used during study procedure, Prostatic Artery Embolization (PAE) to reduce or eliminate bloodflow to the prostate.
干预措施: Embozene Microspheres (Device)
结局指标
主要结局
Clinical improvement in Lower Urinary Tract Symptoms (LUTS)
时间窗: 24 months
QMax assessment
Presence or absence of ischemic complications to the bladder, rectum, or other pelvic structures
时间窗: 24 months
次要结局
- Urine flow rate as measured by QMax(24 months)
- UCLA-PCI-SF (University of California, Los Angeles Prostate Cancer Index Short Form) score(1 month)
- UCLA-PCI-SF score(24 months)
- Post-void residual measured in ml/cc(24 months)
研究者
Ziv Haskal, MD
Principal Investigator
University of Virginia