Relationship bw Image-deriv Features of Intraoperative ICG Visualiz of NVBs During RARP & Functional Outcome

Prostate Adenocarcinoma Clinical Trial

Official title:

Relationship Between Image-derived Features of Intraoperative ICG Visualization of Periprostatic Vasculature and NVBs During RARP and Functional Outcomes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06446648
• Other study ID #: 4845
• Secondary ID: UCI 23-137
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 15, 2024
• Est. completion date: June 2028

Study information

• Verified date: May 2024
• Source: University of California, Irvine
• Contact: Chao Family Comprehensive Cancer Center University of California
• Phone: 1-877-827-8839
• Email: ucstudy[@]uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 2028
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Patients must be =18 years old, male, and sexually active.
• 2. Histologically/pathologically confirmed localized prostate adenocarcinoma.
• 3. Adequate preoperative sexual defined as a score of =18 on the Sexual Health Inventory for Men (SHIM) questionnaire.
• 4. Patients who are candidates for good nerve sparing preoperatively determined by PI by assessing imaging findings.
• 5. Ability to read, write and understand and willingness to sign a written informed consent.
• 6. Patients must pass medical clearance from primary care provider and cardiologist, if applicable.
• 7. Patient must be determined to be medical fit for RARP by Investigator.

Exclusion Criteria:

• 1. No locally advanced or metastatic prostate adenocarcinoma.
• 2. Preoperative diagnosis of erectile dysfunction and with any history of intervention for sexual dysfunction such as intrapenile injections and intrapenile prosthesis implant.
• 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. Patients who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by PI
• 6. Patients who are unable to comply with study and follow-up procedures as judged by the PI.
• 7. Patients 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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma

Intervention

Drug:
• ICG
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.

Locations

Country	Name	City	State
United States	Chao Family Comprehensive Cancer Center University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Continence 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.	3 months
Secondary	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	12 months