Firefly Fluorescent Imaging + IS-002 for Prostate Cancer

No longer recruiting at 3 trial locations

Overseen By Alina Lim

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Intuitive Surgical

Must not be taking: Investigational agents

Disqualifiers: Bone metastasis, Hepatitis B/C, Liver/kidney disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help surgeons identify prostate cancer during surgery. It uses a special drug, IS-002 (an experimental treatment), and near-infrared light to highlight cancerous areas, making removal more accurate. Two groups participate: one receives the drug without the light, and the other receives both. Men with confirmed prostate cancer facing surgery might be suitable, especially if they have aggressive cancer features like a high Gleason score or regional lymph node involvement. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in prostate cancer surgery.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have received certain therapies like hormonal therapy or are currently on an investigational drug, you may not be eligible.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IS-002 is safe and well-tolerated by patients. One study found that patients with high-risk prostate cancer did not experience any major safety issues when using IS-002 during surgery. It also enhanced the visibility of tumors for doctors during the operation.

Firefly fluorescence imaging, a technology used in surgeries, helps doctors see different parts of the body more clearly. This system has been used in many surgeries and is generally considered safe.

These findings suggest that both IS-002 and Firefly imaging are safe options for individuals undergoing prostate cancer surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Firefly Fluorescent Imaging combined with IS-002 for prostate cancer because it offers a new way to visualize cancerous tissues during surgery. Unlike standard treatments that rely solely on the surgeon's skill and standard imaging techniques, this method uses fluorescence to highlight cancer cells, potentially making surgeries more precise. This could lead to more effective removal of cancerous tissue while sparing healthy areas, possibly reducing the risk of recurrence and improving recovery outcomes. Additionally, the use of robotic-assisted laparoscopic surgery with pelvic lymph node dissection provides a minimally invasive approach, which can mean less pain and quicker recovery for patients.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that IS-002, when combined with near-infrared (NIR) fluorescence imaging, significantly enhances the visibility of prostate cancer during surgery. One study found that IS-002 identified prostate tumors in 95.8% of patients. This improved visibility can help surgeons remove cancerous tissue more precisely. In this trial, some participants will receive IS-002 with intraoperative near-infrared imaging, while others will receive IS-002 without the imaging. The treatment has also proven safe for patients undergoing surgery. Additionally, using IS-002 with this imaging technique may reduce the risk of missing cancerous tissue during prostate surgery. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Men aged 18-75 with confirmed prostate cancer, willing to undergo surgery using a specific robotic system. They must have a high risk of aggressive disease based on certain clinical criteria and be able to follow study procedures. Men who've had recent investigational therapies, liver or kidney diseases, or treatments like hormone therapy in the last 4 months can't join.

Inclusion Criteria

My prostate cancer is advanced, with a high CAPRA score, significant tumor size, high Gleason score, or suspected spread to lymph nodes.

My prostate cancer is confirmed as adenocarcinoma.

I am scheduled for a specific prostate surgery using a da Vinci robot with Firefly imaging.

Exclusion Criteria

Subject has any other condition or personal circumstance that, in the judgment of the site Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile

Subject is currently receiving an investigational therapeutic agent; or has participated in a study of an investigational therapeutic agent within the past 6 months prior to the day of IS-002 infusion; or is involved in a significant risk investigational device study within the past 6 months prior to the day of IS-002 infusion

I have an active hepatitis B or C infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robotic-assisted radical prostatectomy with IS-002 administration and optional fluorescence imaging

1 day

1 visit (in-person)

Immediate Post-Treatment Monitoring

Participants are monitored for pharmacokinetics and immediate adverse events post-IS-002 administration

24 hours

Follow-up

Participants are monitored for safety, effectiveness, and recurrence of prostate cancer

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Firefly fluorescent imaging
• IS-002
• Robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Trial Overview

The trial is testing IS-002 alongside near-infrared imaging during robotic-assisted surgery for prostate cancer. It aims to improve tumor identification and removal accuracy using the da Vinci Surgical System equipped with Firefly Fluorescence Imaging.

How Is the Trial Designed?

Group I: RARP + IS-002 + intraoperative near-infrared imaging Experimental Treatment 3 Interventions

Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.

Group II: RARP + IS-002 Placebo Group 2 Interventions

Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.

Who Is Running the Clinical Trial?

Intuitive Surgical

Lead Sponsor

Trials

80

Recruited

49,600+

Gary Guthart

Intuitive Surgical

Chief Executive Officer since 2010

PhD in Engineering, California Institute of Technology

Henry Charlton

Intuitive Surgical

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

Fluorescent probes in the near-infrared (NIR) range, such as human neuropeptide 401 (HNP401), show great promise for improving the identification of critical structures like nerves and tumor margins during prostate surgery, enhancing surgical precision and safety.

The development of specialized imaging technologies, including multiphoton microscopy and confocal laser endomicroscopy, is crucial for effectively utilizing these fluorescent probes in the operating room, with ongoing research aimed at overcoming challenges related to size and magnification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Fluorescent Image Guidance for Nerve-Sparing Prostatectomy: A Review of Historical Context and Current Research. Mandel, A., Das, C., Ting, R., et al.[2023]

In a systematic review of 5 studies involving 1,308 patients, the use of a peritoneal interposition flap (PIF) during robot-assisted radical prostatectomy significantly reduced the rate of symptomatic lymphoceles (sLCs) to 1.3%, compared to 5.7% in the standard group (p < 0.001).

However, a prospective randomized study (Pianoforte trial) did not find a significant difference in sLC rates between PIF and standard techniques, indicating that more research is needed to conclusively determine the effectiveness of PIF in reducing sLCs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Importance of a Peritoneal Interposition Flap to Prevent Symptomatic Lymphoceles after Robot-Assisted Radical Prostatectomy and Pelvic Lymph Node Dissection: A Systematic Review and Meta-Analysis. Deutsch, S., Hadaschik, B., Lebentrau, S., et al.[2022]

In a large-scale review involving 8240 robotic-assisted laparoscopic prostatectomies (RALPs) performed by experienced surgeons, critical robotic equipment malfunctions occurred in only 0.4% of cases, indicating a high reliability of the da Vinci robotic system.

Most malfunctions involved the robotic arms and optical system, but only 34 cases experienced critical failures, leading to 24 cancellations and 10 conversions to other surgical methods, demonstrating that while malfunctions can happen, they are quite rare in high-volume settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic equipment malfunction during robotic prostatectomy: a multi-institutional study. Lavery, HJ., Thaly, R., Albala, D., et al.[2016]

In a study of 1740 patients undergoing robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection, 6% were found to have positive lymph nodes, and the median follow-up was 26 months.

Patients with two or fewer positive lymph nodes and a Gleason score of less than 8 had a better chance of remaining free from biochemical recurrence, suggesting that careful selection of patients may lead to favorable outcomes without the need for adjuvant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic-assisted pelvic lymph node dissection for prostate cancer: frequency of nodal metastases and oncological outcomes. Ledezma, RA., Negron, E., Razmaria, AA., et al.[2018]

Robotic-assisted laparoscopic prostatectomy (RALP) demonstrated high safety with no conversions to open surgery or re-operations in the first 100 cases studied, with an average blood loss of only 281 ml and a short hospital stay of 1.1 nights.

Efficacy results showed an 18% positive margin rate overall, with only 8% for pT2 tumors, and 68% of patients reported no incontinence at 12 months, indicating RALP is effective in managing prostate cancer with favorable postoperative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. Duthie, JB., Pickford, JE., Gilling, PJ.[2011]

Indocyanine green-guided extended pelvic lymph node dissection during robot-assisted radical prostatectomy successfully identified lymphatic drainage patterns in 100 patients with intermediate- to high-risk prostate cancer, revealing five main lymphatic pathways.

While the method showed limited sensitivity (34%) and specificity (64.8%) for identifying metastatic lymph nodes, it still provides valuable insights into lymphatic pathways that can enhance the quality of surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of indocyanine green-guided extended pelvic lymph node dissection during robot-assisted radical prostatectomy. Shimbo, M., Endo, F., Matsushita, K., et al.[2021]

The study involving 18 patients demonstrated that the PSMA-targeted fluorescent tracer OTL78 was well tolerated, with no drug-related toxicity leading to dose reductions or discontinuations, indicating its safety for use in prostate cancer surgery.

OTL78 showed potential for improving prostate cancer detection during robot-assisted radical prostatectomy, with optimal dosing identified as 0.03 mg/kg administered 24 hours before surgery, allowing for real-time identification of cancerous tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-patient study of OTL78 for intraoperative fluorescence imaging of prostate-specific membrane antigen-positive prostate cancer: a single-arm, phase 2a, feasibility trial. Stibbe, JA., de Barros, HA., Linders, DGJ., et al.[2023]

Fluorescence laparoscopy significantly enhances the detection of positive pelvic lymph nodes in prostate cancer patients, achieving a sensitivity of 100% and specificity of 100% for certain lymph node groups.

In a study of 45 prostate cancer patients, fluorescence imaging allowed for the identification of 134 lymph nodes, with a notable detection rate of positive nodes, indicating its clinical value in managing intermediate- and high-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical value of fluorescence laparoscopy in pelvic lymph node dissection for intermediate- and high-risk prostate cancer patients]. Wang, RJ., Shen, JW., Tang, JE., et al.[2023]

The study evaluated 12 men with high-risk prostate cancer and found that robot-assisted 99mTc-based PSMA-radioguided surgery is safe and feasible, with no significant complications reported beyond Clavien-Dindo Grade I.

The use of a DROP-IN γ-probe during surgery improved the detection of metastatic lymph nodes, identifying 11 nodes not seen on preoperative imaging, demonstrating a sensitivity of 76% and specificity of 69% in vivo, and even higher accuracy in ex vivo assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Assisted Prostate-Specific Membrane Antigen-Radioguided Surgery in Primary Diagnosed Prostate Cancer. Gondoputro, W., Scheltema, MJ., Blazevski, A., et al.[2023]

In a study of 330 patients undergoing radical prostatectomy, pelvic lymph node dissection (PLND) was performed with high lymph node yields across different surgical approaches, with open radical retropubic (ORP) and laparoscopic (LRP) yielding more nodes than robot-assisted laparoscopic prostatectomy (RALP).

The study found that individual surgeon performance significantly influenced the number of lymph nodes removed, suggesting that a surgeon's commitment to PLND is more critical for outcomes than the specific surgical approach used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pelvic lymph node dissection for patients with elevated risk of lymph node invasion during radical prostatectomy: comparison of open, laparoscopic and robot-assisted procedures. Silberstein, JL., Vickers, AJ., Power, NE., et al.[2021]

Robot-assisted laparoscopic surgery for rectal cancer, when combined with robot-assisted radical prostatectomy (RARP), was successfully performed in all five cases studied, demonstrating its feasibility.

The procedure had a median operation time of 529 minutes and minimal blood loss (307 ml), with no patients requiring transfusions or experiencing severe complications, indicating a safe surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical impact of robot-assisted laparoscopic rectal cancer surgery associated with robot-assisted radical prostatectomy. Maeda, A., Takahashi, H., Watanabe, K., et al.[2022]

In a study of 1047 patients undergoing radical prostatectomy, those who had robot-assisted laparoscopic prostatectomy (RALP) had significantly higher lymph node yields (7.1) compared to those who had traditional open retropubic radical prostatectomy (RRP) (6.0), indicating that RALP is effective for pelvic lymph node dissection (PLND).

The rate of lymph node involvement was similar between the two surgical approaches (1.1% for RALP vs. 2.3% for RRP), and complications related to PLND were also comparable, suggesting that RALP is a safe alternative to RRP for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of lymph node yield in robot-assisted laparoscopic prostatectomy with that in open radical retropubic prostatectomy. Lallas, CD., Pe, ML., Thumar, AB., et al.[2011]

In a study of 317 patients undergoing robotic radical prostatectomy (RARP) at a medium-volume center, 30.3% experienced complications, mostly minor (84.4% classified as Clavien grade 1 and 2), indicating a generally high safety profile for the procedure.

The nerve-sparing surgical technique was identified as an independent predictor of complications, suggesting that while it may be beneficial for preserving function, it could also increase the risk of postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current evidence between hospital volume and perioperative outcome: Prospective assessment of robotic radical prostatectomy safety profile in a regional center of medium annual caseload. Ferrari, M., Mazzola, B., Roggero, E., et al.[2021]

In a study of 603 patients who underwent nerve-sparing robot-assisted radical prostatectomy (NS RARP) over 10 years, the achievement of Pentafecta outcomes (which include potency, continence, and absence of complications) increased from 38% to 44%, indicating improved surgical results over time.

The distribution of risk groups among patients shifted, with more patients classified as intermediate-risk, and the ability to achieve Pentafecta outcomes was found to be dependent on risk group, particularly with biochemical recurrence being a significant barrier in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in risk-group distribution and Pentafecta outcomes in patients treated with nerve-sparing, robot-assisted radical prostatectomy: a 10-year low-intermediate volume single-center experience. Afferi, L., Moschini, M., Baumeister, P., et al.[2021]

Citations

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NCT05946603 | IS-002 Phase 2 Prostate Cancer Study

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First-in-human Evaluation of a Prostate-specific Membrane ...

In this study, we tested IS-002 for the first time in men with high-risk prostate cancer undergoing surgery and found that IS-002 is safe, is cleared from the ...

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IS-002 Improves Prostate Cancer Visualization Prior to ...

Additionally, ex vivo imaging confirmed IS-002 prostate tumor signal in 95.8% of patients. Study authors noted that the study treatment ...

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In this trial, omitting biopsy in patients with negative MRI results eliminated more than half of diagnoses of clinically insignificant prostate cancer.

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First-in-human Evaluation of a Prostate-specific Membrane ...

In this study, we tested IS-002 for the first time in men with high-risk prostate cancer undergoing surgery and found that IS-002 is safe, is ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8423683/

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Combined use of complementary fluorescent emissions can allow visualization of different anatomical structures (e.g. tumor, lymphatics and ...

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pmc.ncbi.nlm.nih.gov/articles/PMC4350927/

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This study demonstrated that the FireFly endoscopic camera system of the Da Vinci Si surgical system can image fluorescent SLNs resulting from an 8.4-nmol ...

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In this review, we provide examples of applications of fluorescence imaging in urologic, gynecologic, general, and endocrine surgeries.