Prostate AdenocarcinomaEarly Phase 1NCT06446648
Impact of Intraoperative ICG on Functional Outc in RARP
A Early Phase 1 study testing ICG in people with Prostate Adenocarcinoma, run by University of California, Irvine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- ICG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to Jul 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
United States1 site, 1 recruiting
- Recruiting
Chao Family Comprehensive Cancer Center University of California, Irvine
Orange, California, 92868
David Lee, MD, 877-827-8839, ucstudy@uci.edu
About this study
Official title: Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
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.
Read the 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.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- ICG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGDrug
Also called Indocyanine Green
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.
| Study group | Role | What they receive |
|---|---|---|
| SOC group | No intervention | Robot-Assisted Radical Prostatectomy will be performed as a standard procedure. |
| ICG group | Experimental | Robot-Assisted Radical Prostatectomy using ICG Receives: Drug: ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start12 Jul 2024
- Primary completionJul 2028 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Inkoo Lee, University of California, Irvine
- Investigators
- David Lee, MD, Principal investigator, Chao Family Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446648
- Sponsor's protocol ID
- 4845
- Other IDs
- UCI 23-137
- Status last verified
- Feb 2026
- First submitted
- 31 May 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative ICG Use During Robotic-Assisted Radical Prostatectomy on Functional Outcomes
- ClinicalTrials.gov ID
- NCT06446648
- Acronym / sponsor ID
- 4845
- Conditions
- Prostate Adenocarcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC group | No intervention | –Robot-Assisted Radical Prostatectomy will be performed as a standard procedure. |
| ICG group | Experimental | Drug: ICGRobot-Assisted Radical Prostatectomy using ICG |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICGAlso: Indocyanine GreenAdminister 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. | Drug | ICG group |
Primary outcome
Continence Rate at 3 month Post-surgery
Time frame: 3 months
Number of patients who report using no pads or only 1 security pad per day at 3-month post-surgery.
1 secondary outcome
Patient Reported Continence and Sexual Functions
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chao Family Comprehensive Cancer Center University of California, Irvine contact
University of California Irvine Medical contact
David Lee, MD principal investigator
Chao Family Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ICG in people with Prostate Adenocarcinoma, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chao Family Comprehensive Cancer Center University of California, Irvine (1-877-827-8839, ucstudy@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continence Rate at 3 month Post-surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.