Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients With Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in International Prostate Symptom Score
研究概览
简要总结
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade groups 1 and 2) who are eligible for and who select XRT as their cancer management method.
- •Ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy.
- •Ability to understand and the willingness to sign a written informed consent document
- •Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans
- •American Urologic Association (AUA) or International Prostate Symptom Score (IPSS) Score ≥ 15
- •Normal organ and marrow function as defined in protocol
排除标准
- •Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
- •Receiving androgen deprivation therapy (ADT)
- •Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
- •Receiving any investigational agents for the explicit purpose of prostatic size reduction
- •Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of definitive radiation therapy
- •Active urinary tract infection (UTI)
- •History of severe allergic reaction to intravenous contrast media (iodinated and gadolinium- based) or any agents used during the PAE; patient cannot be medicated against allergic reaction prior to PAE.
- •Active cystolithiasis or prostatitis
- •Inability to have multi-parametric magnetic resonance imaging (mpMRI)
- •Prior transurethral resection of the prostate (TURP) within 2 years
- •Prostate size greater than or equal to150 grams
- •Vulnerable subjects (e.g., inmates and developmentally delayed adults) who are subjects for whom the study may be unsafe or whose rights may be violated with enrollment.
研究组 & 干预措施
Prostatic Artery Embolization (PAE)
Participants who receive PAE with Merit Medical Embospheres.
干预措施: Radiation Therapy (Radiation)
Prostatic Artery Embolization (PAE)
Participants who receive PAE with Merit Medical Embospheres.
干预措施: Merit Medical Embospheres (Device)
结局指标
主要结局
Change in International Prostate Symptom Score
时间窗: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".
次要结局
- Prostate Volume Reduction after PAE(At 12 weeks)
- Change in American Urologic Association Score(At 18 weeks)