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ICG for Prostate Cancer Surgery Outcomes

This study is looking at whether using a special dye called indocyanine green (ICG) during robot-assisted radical prostatectomy (RARP) can help improve outcomes for men with prostate adenocarcinoma (a type of prostate cancer). The ICG is given through an IV during surgery to help surgeons see arteries better. The main goal is to see if this approach improves your ability to control your bladder (continence) three months after surgery. You might be able to join if you are a man at least 18 years old with confirmed localized prostate cancer, have a good preoperative sexual health score, and are a good candidate for nerve-sparing surgery. The study is currently unclear about its recruitment status.

Study design
This is a three-phase study, starting with 50 participants to create a 3D map, followed by another 50 to find the best ICG dose, and then a randomized trial with 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your continence rate will be measured at 3 months post-surgery, and sexual function outcomes will be assessed at 12 months postoperatively.

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NCT06446648

Impact of Intraoperative ICG on Functional Outc in RARP

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
University of California, Irvine
~400 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:ICG

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Continence Rate at 3 month Post-surgery
Measured over 3 months

Conditions

Prostate Adenocarcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

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

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Continence Rate at 3 month Post-surgery3 months

    Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery.