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New treatment option for Prostate Adenocarcinoma
Official title Impact of Intraoperative ICG on Functional Outc in RARP
ClinicalTrials.gov ID: NCT06446648
What this study is testing
What is ICG?
ICG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate adenocarcinoma.
Also referred to as Indocyanine Green.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 1\. people 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\. people 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.
You likely can't join if
- 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...
- 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\. people who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by the investigator.
- 6\. people who are unable to comply with study and follow-up procedures as judged by the investigator.
See the full eligibility criteria
- 1\. people 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\. people 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\. people 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 or hypersensitivity attributed to iodide compounds, ICG, or any component of ICG.
- 5\. people who are preoperatively not foreseen as ideal candidates for nerve sparing interventions by the investigator.
- 6\. people who are unable to comply with study and follow-up procedures as judged by the investigator.
- 7\. people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.