NCT05946603CompletedPhase 2
IS-002 Phase 2 Prostate Cancer Study
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 59 (actual)
- First submitted
- 28 Jun 2023
- Start date
- 16 Jun 2023
- Primary completion date
- 21 May 2024
- Lead sponsor
- Intuitive Surgical
- Diseases
- Prostate cancer
- NCT number
- NCT05946603
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 59
- From 16 Jun 2023 to the primary completion date, 21 May 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- 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.
Lab values
- 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
Other
- Subject has known bone metastasis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| MSKCC Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| UCSF Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.