Recruiting
Early Phase 1

ICG

Sponsor:

UCLA

Code:

NCT06446648

Conditions

Prostate Adenocarcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ICG

Study Details

Brief summary:

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 ID

NCT06446648

Start date

Jul 12, 2024

Status verified date

Feb, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: SOC group

Robot-Assisted Radical Prostatectomy will be performed as a standard procedure.

experimental: ICG group

Robot-Assisted Radical Prostatectomy using ICG

Interventions

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.

Primary outcome measure

  • Continence Rate at 3 month Post-surgery [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

David Lee, MD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-03-03.