Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Continence Rate at 3 month Post-surgery
研究概览
简要总结
This is a pilot, 3 phases open-label feasibility study with the 3rd phase consisting of randomized 2-arm intervention trial, to assess the systematic use of indocyanine green (ICG) in subjects with prostate adenocarcinoma during robot-assisted radical prostatectomy and its impact on sexual function outcomes at 12 months postoperatively.
详细描述
The first phase of this study will involve performing 50 cases of nerve-sparing RARP on patients who are good candidates for nerve sparing. During these procedures, we will record the location and size of arteries encountered to create a detailed 3D map of the surgical arterial vasculature.
In the second phase, we will recruit another 50 patients. These patients will receive an IV injection of ICG before encountering the arteries to visualize them prior to resection. This phase will determine the optimal dosage and timing for the IV ICG injection.
The third phase will utilize the dosage and timing defined in the second phase. This phase will be a randomized trial involving 300 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1. Subjects must be ≥18 years old and male.
- •2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
- •3. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥
- •4. Subjects who are candidates for good nerve sparing preoperatively determined by the investigator by assessing imaging findings.
- •5. Ability to read, write and understand and willingness to sign a written informed consent.
- •6. Subjects must pass medical clearance from primary care provider and cardiologist, if applicable.
- •7. Subject must be determined to be medical fit for RARP by the investigator.
排除标准
- •1. No locally advanced or metastatic prostate adenocarcinoma.
- •2. Preoperative diagnosis of erectile dysfunction with any use of invasive interventions such as intrapenile injections and intrapenile prosthesis implants. Oral interventions are acceptable and are not exclusionary.
- •3. Received neoadjuvant treatment for high-risk prostate cancer or received prior focal treatment of the prostate or prior definitive radiotherapy.
- •4. History of allergic reactions or hypersensitivity attributed to iodide compounds, ICG, or any component of ICG.
- •5. Subjects who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by the investigator.
- •6. Subjects who are unable to comply with study and follow-up procedures as judged by the investigator.
- •7. Subjects who are illiterate.
- •8. Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, or uncontrolled diabetes.
- •9. Any other disease, metabolic disorder, or abnormal finding upon physical examination or laboratory examination that makes the subject unsuitable for receiving the intervention, affects the interpretation of study outcomes, or poses risks to subject safety, as determined by the investigator.
研究组 & 干预措施
ICG group
Robot-Assisted Radical Prostatectomy using ICG
干预措施: ICG (Drug)
SOC group
Robot-Assisted Radical Prostatectomy will be performed as a standard procedure.
结局指标
主要结局
Continence Rate at 3 month Post-surgery
时间窗: 3 months
Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery.
次要结局
- Patient Reported Continence and Sexual Functions(12 months)
研究者
David Inkoo Lee
Professor of Clinical Urology
University of California, Irvine