Actively Recruiting
Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
Led by University of California, Irvine · Updated on 2026-03-03
400
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of indocyanine green ICG during robot-assisted radical prostatectomy RARP to study its impact on sexual function and continence outcomes in men with prostate adenocarcinoma. This pilot study includes three phases, with the third phase being a randomized trial comparing standard RARP to RARP with ICG use. The study focuses on how ICG might help visualize arteries during surgery and potentially improve postoperative functional results at 12 months. The studys first phase involves performing 50 nerve-sparing RARP procedures to map the arteries around the prostate using 3D imaging. In the second phase, another 50 patients will receive an intravenous injection of ICG to visualize arteries before removal, helping to determine the best dose and timing of ICG. The third phase is a randomized trial with 300 patients, comparing standard RARP to RARP with ICG guided by the 3D vascular map. Participants will undergo assessments of continence three months after surgery and report continence and sexual function outcomes at 12 months. The study monitors patient-reported outcomes and surgical results to evaluate the impact of ICG use. The total participation involves preoperative evaluation, surgery, and follow-up visits extending to at least 12 months post-surgery.
CONDITIONS
Brief Title
Impact of Intraoperative ICG on Functional Outc in RARP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 18 years or older
- 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 surgery based on preoperative imaging assessment
- Ability to read, write, understand, and willing to sign informed consent
- Medical clearance from primary care provider and cardiologist if applicable
- Medically fit for robot-assisted radical prostatectomy as determined by investigator
You will not qualify if you...
- Presence of locally advanced or metastatic prostate adenocarcinoma
- Preoperative diagnosis of erectile dysfunction requiring invasive interventions such as intrapenile injections or prosthesis implants
- Prior neoadjuvant treatment for high-risk prostate cancer or previous focal treatment or definitive radiotherapy of the prostate
- History of allergic reactions or hypersensitivity to iodide compounds, ICG, or its components
- Not considered ideal candidates for nerve-sparing surgery by the investigator
- Inability to comply with study and follow-up procedures
- Illiteracy
- Serious uncontrolled diseases affecting compliance or outcome interpretation, including active severe infections or uncontrolled diabetes
- Any other medical condition or abnormal finding rendering the subject unsuitable for the intervention or affecting safety or study results as judged by the investigator
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
U
University of California Irvine Medical
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