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Impact of Intraoperative ICG on Functional Outc in RARP

UCI Specialty Area: Cancer
Principal Investigator: David Lee
Official Title: Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
A Study On:
Prostate

Study Description

Eligibility

  1. Age 18 years old or older, male, and sexually active.
  2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
  3. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥16 .
  4. 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 form.
  6. Must be determined to be medical fit for robot-assisted radical prostatectomy (RARP) by the investigator
  1. No locally advanced or metastatic prostate adenocarcinoma.
  2. Preoperative diagnosis of erectile dysfunction with use of invasive interventiosn for sexual dysfunction such as intrapenile injections and intrapenile prosthesis implant. 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. 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.
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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