NCT06446648 · University of California, Irvine
Impact of Intraoperative ICG on Functional Outc in RARP
What this study is about
This is a pilot, 3 phases where both patients and doctors know the treatment given feasibility study with the 3rd phase consisting of randomly assigned 2-treatment group$1 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 be medical fit for RARP by the investigator.
Exclusion criteria
- 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.
Where
- Orange, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations