Prostate CancerPhase 2NCT05946603
IS-002 Phase 2 Prostate Cancer Study
A Phase 2 study testing Administration of IS-002, Firefly fluorescent imaging and robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection in people with Prostate Cancer, run by Intuitive Surgical at 4 sites in United States.
Trial summary
Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Administration of IS-002, Firefly fluorescent imaging and robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Jun 2023to 23 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 to 75.
- Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.
- Subject has CAPRA ≥6; or ≥T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score ≥8; or regional lymphadenopathy suspicious for nodal metastases on imaging.
- Subject is scheduled to undergo robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using a da Vinci® X/Xi Surgical System equipped with Firefly® Fluorescence Imaging.
- Subject is willing and able to provide written informed consent.
- Subject can comply with the study procedures and study visits and understands an informed consent document.
Who cannot join
- Subject has known bone metastasis.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject has a known history of acute or chronic liver or kidney disease.
- Renal function at screening: i. Creatinine clearance: <50 mL/min as determined using the Cockcroft-Gault formula ii. Albumin: <LLN
- Hepatic function at screening: i. AST and/or ALT: >2.5x ULN ii. Total Bilirubin (serum): >1.5x ULN
- Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.
- 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.
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins
Baltimore, Maryland, 21287
MSKCC
New York, New York, 10065
Mayo Clinic
Rochester, Minnesota, 55905
UCSF
San Francisco, California, 94158
About this study
Official title: Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescence Imaging
Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.
- Conditions
- Prostate Cancer
- Being tested
- Administration of IS-002, Firefly fluorescent imaging, robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of IS-002Drug
Intravenous administration of IS-002 approximately 24 hours prior to surgery
Firefly fluorescent imagingDevice
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002
robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissectionProcedure or surgery
Also called RARP
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
| Study group | Role | What they receive |
|---|---|---|
| RARP + IS-002 | Sham comparator | Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed. Receives: Drug: Administration of IS-002; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection |
| RARP + IS-002 + intraoperative near-infrared imaging | Experimental | Subjects will receive IS-002, and during surgery fluorescence imaging will be performed. Receives: Drug: Administration of IS-002; Device: Firefly fluorescent imaging; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
Measured: Within 3 months post-surgery
The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
Measured: Within 3 months post-surgery
Secondary outcomes (6)
Diagnostic performance of IS-002 fluorescence
The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.
Measured: Up to 1 year post-surgery
Safety: Adverse event assessment
Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0
Measured: Up to 1 year post-surgery
Pharmacokinetics: Area under the concentration-time curve (AUC)
Area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration as calculated by linear up/log down trapezoidal method (AUC0-last)
Measured: Up to 24 hours post-IS-002 administration
Time to biochemical recurrence (BCR)
Time to BCR in the Intervention arm and the Control arm. BCR is defined a PSA level >0.1 ng/mL as determined by an ultrasensitive PSA assay.
Measured: Up to 1 year post-surgery
Time to secondary treatment initiation
Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.
Measured: Up to 1 year post-surgery
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
In the Intervention arm, the number of intraoperative fluorescent lymph nodes, per subject and per lymph node basin, that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only.
Measured: Up to 3 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start16 Jun 2023
- Primary completion21 May 2024
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946603
- Sponsor's protocol ID
- ISI-142325-2
- Status last verified
- Aug 2025
- First submitted
- 28 Jun 2023
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescence Imaging
- ClinicalTrials.gov ID
- NCT05946603
- Acronym / sponsor ID
- ISI-142325-2
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 21 May 2024 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RARP + IS-002 | Sham comparator | Drug: Administration of IS-002, Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissectionSubjects will receive IS-002, but during surgery NO fluorescence imaging will be performed. |
| RARP + IS-002 + intraoperative near-infrared imaging | Experimental | Drug: Administration of IS-002, Device: Firefly fluorescent imaging, Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissectionSubjects will receive IS-002, and during surgery fluorescence imaging will be performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged 18 to 75.
- Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.
- Subject has CAPRA ≥6; or ≥T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score ≥8; or regional lymphadenopathy suspicious for nodal metastases on imaging.
- Subject is scheduled to undergo robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using a da Vinci® X/Xi Surgical System equipped with Firefly® Fluorescence Imaging.
- Subject is willing and able to provide written informed consent.
Key exclusion criteria (8 listed)
- Subject has known bone metastasis.
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Subject has a known history of acute or chronic liver or kidney disease.
- Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Administration of IS-002Intravenous administration of IS-002 approximately 24 hours prior to surgery | Drug | RARP + IS-002, RARP + IS-002 + intraoperative near-infrared imaging |
| Firefly fluorescent imagingNear-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002 | Device | RARP + IS-002 + intraoperative near-infrared imaging |
| robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissectionAlso: RARPSubject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection | Procedure or surgery | RARP + IS-002, RARP + IS-002 + intraoperative near-infrared imaging |
Primary outcome
The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
Time frame: Within 3 months post-surgery
The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
Time frame: Within 3 months post-surgery
The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
6 secondary outcomes
Diagnostic performance of IS-002 fluorescence
Time frame: Up to 1 year post-surgery
Safety: Adverse event assessment
Time frame: Up to 1 year post-surgery
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Up to 24 hours post-IS-002 administration
Time to biochemical recurrence (BCR)
Time frame: Up to 1 year post-surgery
Time to secondary treatment initiation
Time frame: Up to 1 year post-surgery
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
Time frame: Up to 3 months post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Administration of IS-002, Firefly fluorescent imaging and robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection in people with Prostate Cancer, run by Intuitive Surgical at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm. (time frame: Within 3 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.