Impact of Intraoperative ICG on Functional Outc in RARP

Trial Title: Impact of Intraoperative ICG on Functional Outc in RARP

NCT ID: NCT06446648

Condition: Prostate Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma

Study type: Interventional

Study phase: Early Phase 1

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ICG
Description: Administer an IV ICG injection intraoperatively, using the optimal dosage and timing defined in the second phase of the study. Utilize the newly developed 3D vascular map for visualization of the arteries before and after prostate resection.
Arm group label: ICG group

Other name: Indocyanine Green

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.

Criteria for 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.

Gender: Male

Gender based: Yes

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Chao Family Comprehensive Cancer Center University of California, Irvine

Address:
City: Orange
Zip: 92868
Country: United States

Status: Recruiting

Contact:
Last name: David Lee, MD

Phone: 877-827-8839
Email: ucstudy@uci.edu

Start date: July 12, 2024

Completion date: July 2028

Lead sponsor:
Agency: University of California, Irvine
Agency class: Other

Source: University of California, Irvine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06446648