Using ICG to improve sexual function outcomes after prostate surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.