Phase II Open Label Investigation of the Safety and Efficacy of Pre-Operative Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)
研究概览
简要总结
The purpose of this study is to determine whether pre-operative prostate artery embolization (PAE) reduces intra-operative blood loss and improves surgical outcomes among prostate cancer patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP).
详细描述
Duration of study:
This study will enroll 20 patients, with a target enrollment period of 18 months. Patients who undergo prostate artery embolization (PAE) will have follow-up visits 2 weeks and 6 weeks after PAE. All patients in the study will have post RALRP follow-up visits at 2 weeks, 3 months, 6 months, 9 months, and 12 months after surgery. All patients will continue to be followed according to the usual standard of care following the completion of the study.
Study design:
The first 10 patients who meet all study eligibility criteria and provide consent for participation in the study will receive PAE prior to RALRP. Control patients will be matched 1:1 to PAE patients, according to risk score, and will receive RALRP without PAE. Control patients will be selected after all PAE patients have been enrolled, and need not meet all study eligibility criteria.
The following assessments and evaluations are required for participation in this study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient is 45-79 years old
- •Patient has signed informed consent
- •Patient has biopsy-proven prostate adenocarcinoma with localized disease
- •Patient is a candidate for robot-assisted laparoscopic radical prostatectomy (RALRP)
- •Patient has a prostate size >40 grams
排除标准
- •Active urinary tract infection
- •History of life threatening allergy to iodinated contrast agents
- •Any known condition that limits catheter-based intervention or is a contraindication to embolization (eg shunt or adverse arterial anatomy)
- •Patient is unable to undergo MRI imaging
- •Cardiac condition including congestive heart failure or uncontrolled arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression which required hospitalization within the previous 6 months
- •Baseline serum creatinine level > 1.8 mg/dL
- •Baseline hemoglobin < 8.0 g/dL
- •Active cystolithiasis or prostatitis
- •History of pelvic irradiation or radical pelvic surgery
- •Known major iliac arterial occlusive disease
- •Confirmed or suspected bladder cancer
- •Urethral strictures, bladder neck contracture, or other bladder or urethral pathology that could limit catheterization
- •Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy or patient evaluation may potentially cause injury to sites of previous rectal surgery, e.g. if a transrectal probe is used
- •Previous pelvic irradiation or radical pelvic surgery
- •Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
- •Prior transurethral resection of the prostate or other invasive therapies
- •Coagulation disturbances not normalized by medical treatment
- •Acute urinary retention
- •Hypersensitivity to gelatin products
- •Any contraindication to embolization, including intolerance to vessel occlusion procedures, vascular anatomy/blood flow that precludes catheter placement or embolic agent injection, presence/likely onset of vasospasm, presence/likely onset of hemorrhage, severe atheromatous disease, feeding arteries smaller than distal branches, arteriovenous shunt, and collateral vessel pathways endangering normal territories during embolization or pelvic inflammatory disease
研究组 & 干预措施
Prostate artery embolization (PAE)
10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).
干预措施: Prostate artery embolization (PAE) (Device)
Control
10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center.
结局指标
主要结局
Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)
时间窗: RALRP procedure, up to 3 hours
Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.
次要结局
- Change in Hematocrit(Baseline, RALRP post operative day 1)
- Length of Hospital Stay After RALRP(48 hours post procedure)
- RALRP Duration(RALRP procedure)
- Change in Hemoglobin Compared to Baseline(Baseline, RALRP post operative day)
- Change in Prostate Volume(Baseline, 6 weeks post PAE)
- Return to Continence(An expected average of 1 week post RALRP)
- Change From Baseline in Erectile Function at One Year Post RALRP(Baseline,1 year post RALRP)
- Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer(RALRP procedure)
- Biochemical Recurrence of Prostate Cancer(1 year post RALRP)
- Number of Patients That Required Blood Transfusion(RALRP procedure)
- Histologic Changes in the Prostate After PAE(Between baseline prostate biopsy and RALRP)
- RALRP-related Adverse Events(Through 1 year post RALRP)
- PAE-related Adverse Events(Through 1 year post RALRP)
- Change in PSA Following PAE(6 weeks post PAE)
研究者
Shivank Bhatia
Assistant Professor of Clinical Radiology
University of Miami