RECRUITING

Impact of Intraoperative ICG on Functional Outc in RARP

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes

Quick Facts

Study Start:2024-07-12

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06446648

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

1-877-827-8839

ucstudy@uci.edu

University of California Irvine Medical

CONTACT

Principal Investigator

David Lee, MD

PRINCIPAL_INVESTIGATOR

Chao Family Comprehensive Cancer Center

Study Locations (Sites)

Chao Family Comprehensive Cancer Center University of California, Irvine

Orange, California, 92868

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

David Lee, MD, PRINCIPAL_INVESTIGATOR, Chao Family Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-12

Study Completion Date2028-07

Study Record Updates

Study Start Date2024-07-12

Study Completion Date2028-07

Terms related to this study

Additional Relevant MeSH Terms

Prostate Adenocarcinoma