NCT05415696撤回不适用
Prostatic Artery Embolization (PAE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Prostate Cancer Patients Undergoing Radiation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
研究概览
简要总结
The purpose of this study is to learn if the prostatic artery embolization procedure can reduce urinary tract symptoms in patients with enlarged prostates and prostate cancer.
详细描述
PRIMARY OBJECTIVE
- To evaluate the symptomatic improvement in lower urinary tract symptoms after prostatic artery embolization (PAE)
SECONDARY OBJECTIVES
- To evaluate objective measures of improved urinary obstruction after PAE: urine flow rate, prostate volume, and post-void residual
- To measure effects of PAE on prostate specific antigen (PSA).
- To evaluate if PAE reduces the prostate volume and simplifies radiation therapy
- To evaluate the safety of PAE performed in this patient population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years and ≤ 90 years old
- •Prostate volume ≥ 40 mL and ≤ 300 mL
- •Biopsy proven prostate cancer undergoing radiation therapy
- •Diagnosis of moderate to severe lower urinary tract symptoms (LUTS) defined as at least one of the following:
- •IPSS ≥ 12 or dependent on urinary catheterization, or
- •IPSS Quality of Life (QoL) assessment ≥ 3, and
- •Qmax ≤ 12 mL/sec
- •Ability to understand and willingness to sign the written consent
排除标准
- •Neurogenic bladder disorder due to multiple sclerosis, Parkinson's disease, spinal cord injury, diabetes, etc., as demonstrated on urodynamic testing.
- •Detrusor muscle failure, urethral stenosis, or urinary obstruction due to causes other than prostatic obstruction, as demonstrated on urodynamic testing
- •Bladder diverticula greater than 5 cm or bladder stones greater than 2 cm
- •Other active urogenital cancer
- •Baseline serum creatinine greater than 2 mg/dL
- •Evidence of tortuous or atherosclerotic blood vessels
- •Coagulation disturbances not normalized by medical treatment
- •Allergy to iodinated contrast agents not responsive to steroid premedication regimen
结局指标
主要结局
Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
时间窗: 2 months
Patients will be classified into one of 3 symptom severity categories based on their total IPSS score as follows: Mildly symptomatic: 0-7 Moderately symptomatic: 8-19 Severely symptomatic: 20-35
次要结局
- Mean change from baseline in maximal urinary flow measured(at baseline, 2 months, and 12 months after intervention)
- Mean change from baseline in prostate volume measure(at baseline, 2 months, and 12 months after intervention)
- Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured(at baseline, 2 months, and 12 months after intervention)
- Mean change from baseline in post-void residual measured(at baseline, 2 months, and 12 months after intervention)
- Mean change from baseline prostate specific antigen measure(at baseline, 2 months, and 12 months after intervention)
研究者
Andrew Picel
Clinical Associate Professor, Radiology
Stanford University
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH)Benign Prostatic HyperplasiaNCT02930889University of Minnesota21
已完成
不适用
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate CancerProstatic NeoplasmLower Urinary Tract SymptomsUrological ManifestationsProstatic DiseasesNCT03104907Rigshospitalet, Denmark15
已完成
3 期
Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic HyperplasiaBenign Prostatic HyperplasiaNCT02869971Assistance Publique - Hôpitaux de Paris90
终止
不适用
Prostatic Artery Embolization vs Medication for Benign Prostatic HyperplasiaBPHEnlarged Prostate (BPH)Prostatic HyperplasiaNCT04398966University of North Carolina, Chapel Hill12
已完成
不适用
Clinical Trial of Prostatic Arterial Embolization Versus a Sham Procedure to Treat Benign Prostatic HyperplasiaProstatic Hyperplasia, BenignProstatic Hypertrophy, BenignGenital Diseases, MaleLower Urinary Tract SymptomsProstatic DiseasesNCT02074644João Martins Pisco80