Actively Recruiting
Impact of Intraoperative ICG on Functional Outc in RARP
Led by University of California, Irvine · Updated on 2026-03-03
400
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Intraoperative ICG on Functional Outc in RARP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 18 years old or older and male
- Histologically or pathologically confirmed localized prostate adenocarcinoma
- Most recent preoperative Sexual Health Inventory for Men (SHIM) score of 10 or higher
- Candidates for good nerve sparing before surgery as determined by imaging assessments
- Ability to read, write, understand, and willing to sign written informed consent
- Medical clearance from primary care provider and cardiologist if applicable
- Determined medically fit for robotic-assisted radical prostatectomy by the investigator
You will not qualify if you...
- Locally advanced or metastatic prostate adenocarcinoma
- Preoperative erectile dysfunction treated with invasive interventions such as intrapenile injections or prosthesis implants (oral treatments allowed)
- Prior neoadjuvant treatment for high-risk prostate cancer or prior focal prostate treatment or definitive radiotherapy
- History of allergic reactions or hypersensitivity to iodide compounds, ICG, or its components
- Not considered ideal candidates for nerve-sparing surgery preoperatively
- Unable to comply with study and follow-up procedures
- Illiteracy
- Serious uncontrolled diseases affecting study compliance or interpretation, including active or severe infections or uncontrolled diabetes
- Any other disease or abnormal findings making participation unsafe or affecting results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here