Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Orange, California
Dates
study started
completion around
Principal Investigator
by David Inkoo Lee

Description

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.

Official Title

Relationship Between Image-derived Features of Intraoperative ICG Visualization of Periprostatic Vasculature and NVBs During RARP and Functional Outcomes

Details

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.

Keywords

Prostate Adenocarcinoma, Adenocarcinoma, ICG

Eligibility

You can join if…

Open to males ages 18 years and up

    1. Patients must be ≥18 years old, male, and sexually active.
    1. Histologically/pathologically confirmed localized prostate adenocarcinoma.
    1. Adequate preoperative sexual defined as a score of ≥18 on the Sexual Health Inventory for Men (SHIM) questionnaire.
    1. Patients who are candidates for good nerve sparing preoperatively determined by PI by assessing imaging findings.
    1. Ability to read, write and understand and willingness to sign a written informed consent.
    1. Patients must pass medical clearance from primary care provider and cardiologist, if applicable.
    1. Patient must be determined to be medical fit for RARP by Investigator.

You CAN'T join if...

    1. No locally advanced or metastatic prostate adenocarcinoma.
    1. Preoperative diagnosis of erectile dysfunction and with any history of intervention for sexual dysfunction such as intrapenile injections and intrapenile prosthesis implant.
    1. Received neoadjuvant treatment for high-risk prostate cancer or received prior focal treatment of the prostate or prior definitive radiotherapy.
    1. History of allergic reactions attributed to ICG.
    1. Patients who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by PI
    1. Patients who are unable to comply with study and follow-up procedures as judged by the PI.
    1. Patients who are illiterate.
    1. 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.
    1. 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.

Location

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    Orange California 92868 United States

Lead Scientist at UC Irvine

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06446648
Phase
Phase 1 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 400 study participants
Last Updated