Impact of Intraoperative ICG on Functional Outc in RARP

Description

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.

Conditions

Prostate Adenocarcinoma

Study Overview

Study Details

Study overview

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.

Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes

Impact of Intraoperative ICG on Functional Outc in RARP

Condition
Prostate Adenocarcinoma
Intervention / Treatment

-

Contacts and Locations

Orange

Chao Family Comprehensive Cancer Center University of California, Irvine, Orange, California, United States, 92868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 1. Subjects must be ≥18 years old, male, and sexually active.
  • * 2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
  • * 3. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥16.
  • * 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.
  • * 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 attributed to 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Irvine,

David Lee, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

2028-07