← Back to Search

Other

Firefly Fluorescent Imaging + IS-002 for Prostate Cancer

Phase 2
Recruiting
Research Sponsored by Intuitive Surgical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post-surgery
Awards & highlights

Study Summary

This trial tests a tech combo to help identify prostate cancer during robotic-assisted surgery.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical surgical risks such as bleeding, infection, and reactions related to IS-002 which will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
Secondary outcome measures
Diagnostic performance of IS-002 fluorescence
Number of intraoperative fluorescent lymph nodes that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only
Pharmacokinetics: Area under the concentration-time curve (AUC)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RARP + IS-002 + intraoperative near-infrared imagingExperimental Treatment3 Interventions
Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.
Group II: RARP + IS-002Placebo Group2 Interventions
Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.

Find a Location

Who is running the clinical trial?

Intuitive SurgicalLead Sponsor
73 Previous Clinical Trials
49,199 Total Patients Enrolled
5 Trials studying Prostate Cancer
374 Patients Enrolled for Prostate Cancer

Media Library

IS-002 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05946603 — Phase 2
Prostate Cancer Research Study Groups: RARP + IS-002, RARP + IS-002 + intraoperative near-infrared imaging
Prostate Cancer Clinical Trial 2023: IS-002 Highlights & Side Effects. Trial Name: NCT05946603 — Phase 2
IS-002 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05946603 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this medical experiment in terms of hospitals?

"Currently, this trial is inviting patients from four different locations: San Francisco, Baltimore and New york. Additionally, there are several other sites to choose from in order to facilitate easier travel for participants."

Answered by AI

Is it possible for me to register in this investigation?

"To meet the criteria of this medical study, potential participants should be diagnosed with prostate cancer and between 18 to 75 years old. A total of 60 individuals will be accepted into the trial."

Answered by AI

Is the recruitment of participants ongoing for this experiment?

"Yes, as reported on clinicaltrials.gov this trial is open to new participants. It was introduced on June 16th 2023 and the latest changes were made July 7th 2023. The study team are looking for 60 volunteers across 4 different sites."

Answered by AI

Does this investigation allow participants over the age of 40 to join?

"To be eligible for this study, participants must fall between 18 and 75 years old. Clinicialtrials.gov lists 67 trials specifically suited to minors and 1328 studies available to patients over the age of 65."

Answered by AI

How many participants are being recruited for this research endeavor?

"To complete this trial, 60 eligible patients must take part. These participants can come from sites such as UCSF in San Francisco and Johns Hopkins in Baltimore."

Answered by AI

Is the combination of RARP, IS-002 and intraoperative near-infrared imaging sanctioned by the FDA?

"Our team at Power judged RARP + IS-002 + intraoperative near-infrared imaging to have a safety rating of 2, given that its clinical trial is still in Phase 2 and there currently exists limited data regarding efficacy."

Answered by AI

What primary goals has this clinical research set out to accomplish?

"The primary aim of this 3-month evaluation is to assess the rate of positive surgical margins in both intervention and control arms. Secondary benchmarks include determining false positives/negatives, adverse event assessment, and AUC0-last calculation through linear up/log down trapezoidal method."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IS-002 in Prostate Cancer
2023. "IS-002 in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05946603.
~31 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top