Dye during prostate surgery may boost recovery
NCT ID NCT06446648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests if using a special dye (ICG) during robot-assisted prostate removal helps preserve nerves and improve recovery of bladder control and sexual function. About 400 men with prostate cancer will take part. The goal is to see if the dye leads to better outcomes 12 months after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Chao Family Comprehensive Cancer Center University of California, Irvine
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Can a One-Two radiation punch improve prostate cancer control?
- Can a special PET scan change the course of prostate cancer?
- Can a High-Tech radiation beam hit prostate tumors without harming healthy tissue?
- Can 3D imaging make prostate radiation more precise and worth the cost?
- Can surgery boost control of spread prostate cancer?