Impact of Intraoperative ICG on Functional Outc in RARP

NCT ID: NCT06446648

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-12
• Study Completion Date: 2028-07-31

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.

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.

Conditions

Prostate Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOC group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

ICG group

Robot-Assisted Radical Prostatectomy using ICG

Group Type: EXPERIMENTAL

ICG

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

Other Intervention Names

Indocyanine Green

Eligibility Criteria

Inclusion Criteria

• 1. Subjects must be ≥18 years old, male, and sexually active.
• 2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
• 3. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥16.
• 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 attributed to 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

David Inkoo Lee

Professor of Clinical Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Locations

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

Role: CONTACT

ucstudy@uci.edu

1-877-827-8839

University of California Irvine Medical

Role: CONTACT

Facility Contacts

David Lee, MD

Role: primary

ucstudy@uci.edu

877-827-8839

Other Identifiers

UCI 23-137

Identifier Type: OTHER

Identifier Source: secondary_id

4845

Identifier Type: -

Identifier Source: org_study_id