NCT06446648

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for early_phase_1

Timeline
51mo left

Started Jul 2024

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress31%
Jul 2024Jul 2030

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

May 31, 2024

Last Update Submit

February 27, 2026

Conditions

Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient Reported Continence and Sexual Functions

    12 months

Study Arms (2)

SOC group

NO INTERVENTION

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

ICG group

EXPERIMENTAL

Robot-Assisted Radical Prostatectomy using ICG

Drug: ICG

Interventions

ICGDRUG

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.

Also known as: Indocyanine Green
ICG group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Subjects must be ≥18 years old and male.
  • \. Histologically/pathologically confirmed localized prostate adenocarcinoma.
  • \. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥10.
  • \. Subjects who are candidates for good nerve sparing preoperatively determined by the investigator by assessing imaging findings.
  • \. Ability to read, write and understand and willingness to sign a written informed consent.
  • \. Subjects must pass medical clearance from primary care provider and cardiologist, if applicable.
  • \. Subject must be determined to be medical fit for RARP by the investigator.

You may not qualify if:

  • \. No locally advanced or metastatic prostate adenocarcinoma.
  • \. Received neoadjuvant treatment for high-risk prostate cancer or received prior focal treatment of the prostate or prior definitive radiotherapy.
  • \. History of allergic reactions or hypersensitivity attributed to iodide compounds, ICG, or any component of ICG.
  • \. Subjects who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by the investigator.
  • \. Subjects who are unable to comply with study and follow-up procedures as judged by the investigator.
  • \. Subjects who are illiterate.
  • \. 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.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868, United States

RECRUITING

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • David Lee, MD

    Chao Family Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Urology

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

July 12, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2030

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

US(1)