Prostate Adenocarcinoma
Conditions
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.
Interventions
DRUGICG
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.
Sponsors
University of California, Irvine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continence Rate at 3 month Post-surgery | 3 months | Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Continence and Sexual Functions | 12 months | 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. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORDavid Lee, MD
Chao Family Comprehensive Cancer Center
Outcome results
None listed