Impact of Intraoperative ICG on Functional Outc in RARP

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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Adenocarcinoma
• Intervention / Treatment: Drug: ICG

Detailed 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 timing defined in the second phase. This phase will be a randomized trial involving 300 patients.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 1-877-827-8839; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center University of California, Irvine
      • Contact: David Lee, MD; Phone Number: 877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: SOC group; Robot-Assisted Radical Prostatectomy will be performed as a standard procedure.
Experimental: ICG group; Robot-Assisted Radical Prostatectomy using ICG	Drug: ICG; 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.; Other Names: Indocyanine Green

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Continence Rate at 3 month Post-surgery	Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Continence and Sexual Functions	Subjects will complete the investigator-developed, "Follow Up Continence And Sexual Function" questionnaires. This questionnaire includes questions typically asked in Sexual Health Inventory for Men (SHIM) and International Prostate Symptom Score (IPSS) surveys and assesses postoperative functional outcomes such as urinary continence/leakage, daily pad usage, sexual function such as percentage fullness of erection and postoperative. The scales used are the: Sexual Health Inventory for Men (SHIM), with a minimum value of 1 and a maximum value of 25. A higher score indicates a better outcome, and; the International Prostate Symptom Score (IPSS), with a minimum value of 0 and a maximum of 35. A higher score indicates a worse outcome.	12 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: David Lee, MD, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indoles; Indocyanine Green
• Other Study ID Numbers: 4845; UCI 23-137 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No