Indocyanine Green Dye for Prostate Cancer

Overseen By University of California Irvine Medical

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: University of California, Irvine

Disqualifiers: Metastatic cancer, Erectile dysfunction, Allergic to ICG, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, oral medications for erectile dysfunction are allowed, so you may not need to stop those.

What data supports the effectiveness of the treatment Indocyanine Green Dye for Prostate Cancer?

Research shows that using indocyanine green (ICG) during prostate cancer surgery helps identify and remove cancerous lymph nodes more effectively. This can improve staging and outcomes for patients, especially those at intermediate and high risk. ^{1 2 3 4 5}

How is the drug Indocyanine Green (ICG) unique in treating prostate cancer?

Indocyanine Green (ICG) is unique for prostate cancer treatment because it uses near-infrared fluorescence to help surgeons see and preserve important structures during surgery, making it easier to identify and protect nerves and blood vessels. This approach is different from traditional methods as it enhances visualization during robotic-assisted surgeries, potentially improving surgical outcomes. ^{2 4 5 6 7}

What is the purpose of this trial?

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.

Research Team

David Lee, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Eligibility Criteria

Men over 18 with prostate adenocarcinoma, fit for robot-assisted surgery, and good preoperative sexual function (SHIM score ≥18) can join. They must be able to consent and follow the study plan. Men not suitable for nerve-sparing surgery, with prior prostate treatments or severe health issues like uncontrolled diabetes or advanced infections cannot participate.

Inclusion Criteria

Adequate preoperative sexual defined as a score of ≥18 on the Sexual Health Inventory for Men (SHIM) questionnaire

I am a man over 18 and sexually active.

Ability to read, write and understand and willingness to sign a written informed consent

Exclusion Criteria

My surgeon does not see me as a good candidate for surgery that spares nerves.

I have had initial treatment for aggressive prostate cancer or radiation for prostate cancer.

Patients who are illiterate

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1

Performing 50 cases of nerve-sparing RARP to create a detailed 3D map of the surgical arterial vasculature

Not specified

Phase 2

Recruitment of 50 patients to receive IV injection of ICG to determine optimal dosage and timing

Not specified

Phase 3

Randomized trial involving 300 patients using the dosage and timing defined in Phase 2

Not specified

Follow-up

Participants are monitored for continence and sexual function outcomes post-surgery

12 months

Treatment Details

Interventions

• ICG

Trial Overview The trial is testing if using a dye called indocyanine green (ICG) during robotic surgery for prostate cancer helps maintain sexual function after the operation. It's a three-phase study where in the last phase participants are randomly placed into two groups to compare outcomes.

Participant Groups

Group I: ICG group Experimental Treatment 1 Intervention

Robot-Assisted Radical Prostatectomy using ICG

Group II: SOC group Active Control 1 Intervention

Robot-Assisted Radical Prostatectomy will be performed as a standard procedure.

ICG is already approved in United States, European Union for the following indications:

Approved in United States as Indocyanine Green for:

• Cardiac output measurement
• Hepatic function assessment
• Ophthalmic angiography
• Sentinel lymph node detection

Approved in European Union as Indocyanine Green for:

• Cardiac output measurement
• Hepatic function assessment
• Ophthalmic angiography
• Sentinel lymph node detection

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Findings from Research

In a study of 50 prostate cancer patients undergoing robotic-assisted radical prostatectomy, the use of indocyanine green (ICG) injection during pelvic lymph node dissection significantly improved the identification of metastatic lymph nodes, with 23.9% of dissected nodes showing fluorescence in the ICG group compared to only 1.9% in the non-ICG group.

The ICG-guided approach resulted in a higher detection rate of metastatic lymph nodes, as 88.9% of patients with positive nodes in the ICG group had fluorescent positive nodes, suggesting that ICG may enhance surgical outcomes and staging accuracy in intermediate- and high-risk prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence-guided extended pelvic lymphadenectomy during robotic radical prostatectomy. Özkan, A., Köseoğlu, E., Canda, AE., et al.[2023]

In a study of 62 patients undergoing robot-assisted radical prostatectomy (RARP), the use of indocyanine green (ICG) with near-infrared fluorescence successfully identified prostatic arteries and neurovascular bundles in 100% of cases, enhancing surgical precision.

There were no complications related to the ICG injection, and the use of ICG did not increase the operative time compared to RARP procedures without ICG, indicating its safety and efficiency as an adjunctive tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted nerve-sparing radical prostatectomy using near-infrared fluorescence technology and indocyanine green: initial experience. Mangano, MS., De Gobbi, A., Beniamin, F., et al.[2018]

Indocyanine green (ICG) effectively accumulates in prostate cancer tissues, as demonstrated in both a mouse model and a pilot study involving 4 human patients, indicating its potential for targeted imaging during surgery.

Near-infrared (NIR) fluorescence imaging using ICG successfully identified lymph node metastases in 3 out of 4 patients during robotic pelvic lymph node dissection, suggesting it could enhance the accuracy of detecting cancerous nodes in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Near-infrared Intraoperative Molecular Imaging Can Identify Metastatic Lymph Nodes in Prostate Cancer. Xia, L., Zeh, R., Mizelle, J., et al.[2018]

Fluorescence-enhanced robotic radical prostatectomy (FERRP) using indocyanine green (ICG) for real-time tissue marking was successfully performed on 50 patients, demonstrating safety and feasibility in identifying prostate tissue and sentinel lymph nodes.

The technique achieved a 100% sensitivity for detecting sentinel nodes, although it had a lower specificity of 75.4%, indicating that while it reliably identifies nodes, it may not always accurately predict the presence of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorescence-enhanced robotic radical prostatectomy using real-time lymphangiography and tissue marking with percutaneous injection of unconjugated indocyanine green: the initial clinical experience in 50 patients. Manny, TB., Patel, M., Hemal, AK.[2022]

Indocyanine green (ICG) has been shown to be useful in guiding prostate cancer treatment, particularly in identifying cancerous tissues and aiding in sentinel node dissection during radical prostatectomy, based on a review of literature from 2000 to 2020.

While ICG is considered safe and shows promise in preserving neurovascular structures during surgery, it currently lacks the sensitivity and specificity needed to replace traditional pelvic lymph node dissection, indicating the need for further research and larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of indocyanine green in guiding prostate cancer treatment. Xie, D., Gu, D., Lei, M., et al.[2023]

Indocyanine green (ICG) is increasingly being utilized in fluorescent-guided surgery, enhancing visualization during procedures.

This review highlights the diverse applications of ICG specifically in urologic surgery, showcasing its growing importance in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine Green (ICG) in Urologic Surgery. Kaplan-Marans, E., Fulla, J., Tomer, N., et al.[2020]

Indocyanine green (ICG) combined with diode laser treatment was effective in treating macular and plaque-type Kaposi sarcomas in 6 male patients, with 19 out of 27 lesions resolving completely and no recurrence over a 2-year follow-up.

The treatment had a low side effect profile, with only mild burning sensations reported during irradiation and some transient hyperpigmentation, indicating it is a safe option for palliative care in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photochemotherapy of cutaneous AIDS-associated Kaposi sarcoma with indocyanine green and laser light]. Szeimies, RM., Lorenzen, T., Karrer, S., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Fluorescence-guided extended pelvic lymphadenectomy during robotic radical prostatectomy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Robot-assisted nerve-sparing radical prostatectomy using near-infrared fluorescence technology and indocyanine green: initial experience. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Near-infrared Intraoperative Molecular Imaging Can Identify Metastatic Lymph Nodes in Prostate Cancer. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Fluorescence-enhanced robotic radical prostatectomy using real-time lymphangiography and tissue marking with percutaneous injection of unconjugated indocyanine green: the initial clinical experience in 50 patients. [2022]

5. Singapore pubmed.ncbi.nlm.nih.gov

The application of indocyanine green in guiding prostate cancer treatment. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Indocyanine Green (ICG) in Urologic Surgery. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

[Photochemotherapy of cutaneous AIDS-associated Kaposi sarcoma with indocyanine green and laser light]. [2019]