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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special dye, indocyanine green (ICG), might improve sexual function after prostate surgery. It targets men with prostate cancer planning to undergo robot-assisted surgery. Participants should be sexually active and have a recent history of good sexual health. The trial will compare two groups: one with the dye used during surgery and one without. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to potentially benefit from this innovative approach.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that indocyanine green (ICG) is safe for use in medical procedures. Studies demonstrate that ICG can help doctors see certain tissues more clearly during surgery. Importantly, patients generally tolerate ICG well, with no major safety concerns reported. While these findings are encouraging, they also note that ICG might not always detect all types of tumors accurately. Overall, the existing evidence provides confidence in the safety of ICG for patients considering joining a trial involving this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Indocyanine Green (ICG) dye for prostate cancer because it offers a unique approach to surgery. Unlike standard treatments, which typically involve robot-assisted radical prostatectomy without any special dyes, ICG is used to enhance visualization. This dye lights up lymph nodes and tissues, potentially allowing surgeons to see cancerous areas more clearly and precisely remove them. This could lead to fewer complications and better outcomes for patients, making it a promising development in prostate cancer treatment.

What evidence suggests that ICG is effective for prostate cancer?

This trial will compare the use of indocyanine green (ICG) with standard procedures in prostate cancer surgeries. Research has shown that ICG can aid in treating prostate cancer by enhancing the visibility of tumors and lymph nodes, thus guiding treatment. One study found that ICG alone correctly identified prostate cancer in many cases, with a sensitivity of 71% and a specificity of 68%, demonstrating its accuracy in detection. Additionally, ICG-based imaging has effectively identified prostate tumors and cancer spread to lymph nodes. These findings suggest that using ICG might improve outcomes during prostate cancer surgeries. Participants in this trial will either receive ICG during robot-assisted radical prostatectomy or undergo the procedure without ICG. ^{1 2 4 5 6}

Who Is on the Research Team?

David Lee, MD

Principal Investigator

Chao Family Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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) 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9875158/

The application of indocyanine green in guiding prostate ... Multiple preclinical and clinical studies have shown the usefulness of ICG in identifying and guiding treatment for prostate cancer.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2214388224000912

Review The diagnostic performance of indocyanine green ... Using lymph node-based data, our results showed that the pooled sensitivity and specificity of applying ICG alone in PCa were 71% (95% CI 52%–85%) and 68% (95% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11840311/

A systematic review and meta-analysis - PMC - PubMed Central Almost 15% of prostate cancer (PCa) patients were found to have lymph node metastases (LNMs), which are associated with higher risk of biochemical recurrence.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02840617

ICG-based Fluorescence Imaging in Localization of ... This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of prostate tumors and metastatic lymph nodes ...

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT02260349?cond=Prostate+Cancer&sfpd_s=09%2F13%2F2014

Interest of Indocyanine Green in Neoplastic Prostatic Tissue | ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06411

Intraoperative Imaging with Indocyanine Green for the ... This phase II trial studies whether using indocyanine green (ICG) for imaging taken during surgery (intraoperative) improves functional outcomes in patients ...