Firefly Fluorescent Imaging + IS-002 for Prostate Cancer

Recruiting at3 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Intuitive Surgical

Must not be taking: Investigational agents

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

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new method using IS-002 and special imaging to help surgeons see prostate cancer better during robotic surgery. It aims to improve the accuracy of cancer removal in patients undergoing this procedure.

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.

What data supports the effectiveness of the treatment Firefly Fluorescent Imaging + IS-002 for Prostate Cancer?

The research indicates that robotic-assisted laparoscopic prostatectomy (RARP) with pelvic lymph node dissection (PLND) is a well-established method for treating localized prostate cancer, and the use of robotic assistance in these procedures is associated with varying outcomes. However, specific data on the effectiveness of Firefly Fluorescent Imaging or IS-002 in this context is not directly provided in the available research. ^{1 2 3 4 5}

Is robotic-assisted prostate surgery generally safe for humans?

Robotic-assisted prostate surgery, like robotic-assisted laparoscopic prostatectomy (RALP), is generally considered safe, but there can be complications such as symptomatic lymphoceles (fluid-filled sacs) in up to 10% of cases. Equipment malfunctions can also occur, which might require changing the surgical approach. ^{1 6 7 8 9}

What makes the Firefly Fluorescent Imaging + IS-002 treatment unique for prostate cancer?

This treatment is unique because it uses fluorescent imaging to enhance the precision of robotic-assisted prostate surgery, allowing surgeons to better visualize and preserve important structures like nerves and lymph nodes, potentially improving surgical outcomes and reducing complications. ^{10 11 12 13 14}

Research Team

Eligibility Criteria

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.

I am between 18 and 75 years old.

My prostate cancer is confirmed as adenocarcinoma.

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.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Switzerland 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. [2022]

2. United States 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. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Robotic-assisted pelvic lymph node dissection for prostate cancer: frequency of nodal metastases and oncological outcomes. [2018]

4. Japan pubmed.ncbi.nlm.nih.gov

The clinical impact of robot-assisted laparoscopic rectal cancer surgery associated with robot-assisted radical prostatectomy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of lymph node yield in robot-assisted laparoscopic prostatectomy with that in open radical retropubic prostatectomy. [2011]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Robot-assisted laparoscopic prostatectomy: a 2010 update. [2011]

7. Canada 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. [2021]

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

Robotic equipment malfunction during robotic prostatectomy: a multi-institutional study. [2016]

9. Germany 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. [2021]

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

Intraoperative Fluorescent Image Guidance for Nerve-Sparing Prostatectomy: A Review of Historical Context and Current Research. [2023]

11. China pubmed.ncbi.nlm.nih.gov

[Clinical value of fluorescence laparoscopy in pelvic lymph node dissection for intermediate- and high-risk prostate cancer patients]. [2023]

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

Robot-Assisted Prostate-Specific Membrane Antigen-Radioguided Surgery in Primary Diagnosed Prostate Cancer. [2023]

13. Australia pubmed.ncbi.nlm.nih.gov

Impact of indocyanine green-guided extended pelvic lymph node dissection during robot-assisted radical prostatectomy. [2021]

14. England 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. [2023]