Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Tumor response
研究概览
简要总结
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
详细描述
MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.
This proof of concept study assess the impact of PAE in patients with proven prostate cancer.
PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.
The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men 45 - 75 years old undergoing RALP
- •Patient has biopsy-proven prostate adenocarcinoma
- •Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings
- •Written informed consent
排除标准
- •Severe atherosclerosis
- •Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries
- •Tumor stage > cT2 assessed by clinical and MRI findings
- •Allergy to intravenous contrast media
- •Contraindication for MRI imaging
- •Renal failure (GFR<60ml/min)
- •History of pelvic irradiation or radical pelvic surgery
研究组 & 干预措施
Prostatic Artery Embolization (PAE)
PAE is performed 6weeks before RALP
干预措施: Prostatic Artery Embolization (PAE) (Device)
结局指标
主要结局
Tumor response
时间窗: 6 weeks after PAE (at the time of RALP)
Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate.
次要结局
- Histological Tumor Regression Grade(6 weeks after PAE (at the time of RALP))
- Surgical margins assessment (R0 /R1)(6 weeks after PAE (at the time of RALP))
- Assessment of Adverse Events of PAE according to CTCAE V4.03(At the time of PAE and 6 weeks afterwards)
- Assessment of Adverse Events of PAE according to Clavien-Dindo classification(At the time of PAE and 6 weeks afterwards)
- Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03(At the time of RALP, 6 weeks and 12 weeks later)
- Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification(At the time of RALP, 6 weeks and 12 weeks later)
- Change of prostate volume in MRI after PAE(Before and 6 weeks after PAE)
- Change of tumor detection rate in MRI after PAE(Before and 6 weeks after PAE)
- Change of tumor size in MRI after PAE(Before and 6 weeks after PAE)
- Change of PIRADS classification in MRI after PAE(Before and 6 weeks after PAE)
研究者
Dominik Abt
Dr. med.
Cantonal Hospital of St. Gallen