Clinical trial NCT06446648: Impact of Intraoperative ICG on Functional Outc in RARP
Official title: Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Prostate Adenocarcinoma
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1. Subjects must be ≥18 years old, male, and sexually active.
* 2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
* 3. Most recent preoperative Sexual Health Inventory for Men (SHIM) score ≥16.
* 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 attributed to 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.

Primary outcomes:
measure: Continence Rate at 3 month Post-surgery
timeFrame: 3 months
Secondary outcomes:
measure: Patient Reported Continence and Sexual Functions
timeFrame: 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center University of California, Irvine
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: David Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: