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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
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.
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, United States
RECRUITINGContinence Rate at 3 month Post-surgery
Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery.
Time frame: 3 months
Patient Reported Continence and Sexual Functions
Subjects will complete the investigator-developed, "Follow Up Continence And Sexual Function" questionnaires. This questionnaire includes questions typically asked in Sexual Health Inventory for Men (SHIM) and International Prostate Symptom Score (IPSS) surveys and assesses postoperative functional outcomes such as urinary continence/leakage, daily pad usage, sexual function such as percentage fullness of erection and postoperative. The scales used are the: * Sexual Health Inventory for Men (SHIM), with a minimum value of 1 and a maximum value of 25. A higher score indicates a better outcome, and * the International Prostate Symptom Score (IPSS), with a minimum value of 0 and a maximum of 35. A higher score indicates a worse outcome.
Time frame: 12 months
Chao Family Comprehensive Cancer Center University of California, Irvine
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University of California Irvine Medical
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