Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
University of California, Irvine
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 ≥10. * 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 b…
Interventions
- DrugICG
Administer an IV ICG injection intraoperatively, using the optimal dosage and timing defined in the second phase of the study. Utilize the newly developed 3D vascular map for visualization of the arteries before and after prostate resection.
Location
- Chao Family Comprehensive Cancer Center University of California, IrvineOrange, California