Using ICG to improve sexual function outcomes after prostate surgery
Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
This study is testing whether using a special dye during prostate surgery can help improve sexual function for men after their operation.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Orange, California) |
| Trial ID | NCT06446648 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of indocyanine green (ICG) during robot-assisted radical prostatectomy (RARP) for patients with prostate adenocarcinoma. It consists of three phases: the first phase maps the surgical arterial vasculature in 50 nerve-sparing RARP cases, the second phase determines the optimal dosage and timing of ICG injection in another 50 patients, and the third phase is a randomized trial involving 300 patients to assess the impact of ICG on sexual function outcomes at 12 months post-surgery. The study aims to enhance surgical precision and improve postoperative recovery.
Who should consider this trial
Good fit: Ideal candidates are sexually active men aged 18 and older with localized prostate adenocarcinoma who are suitable for nerve-sparing surgery.
Not a fit: Patients with locally advanced or metastatic prostate adenocarcinoma or those with preoperative erectile dysfunction requiring invasive interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sexual function outcomes for men undergoing prostate surgery.
How similar studies have performed: While the use of ICG in surgical procedures is gaining interest, this specific application in prostate surgery is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Subjects must be ≥18 years old and male. * 2\. Histologically/pathologically confirmed localized prostate adenocarcinoma. * 3\. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥10. * 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 or hypersensitivity attributed to iodide compounds, ICG, or any component of 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.
Where this trial is running
Orange, California
- Chao Family Comprehensive Cancer Center University of California, Irvine — Orange, California, United States (Recruiting)
Study contacts
- Principal investigator: David Lee, MD — Chao Family Comprehensive Cancer Center
- Study coordinator: Chao Family Comprehensive Cancer Center University of California, Irvine
- Email: ucstudy@uci.edu
- Phone: 1-877-827-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.