IS-002 Phase 2 Prostate Cancer Study

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05946603

Run by

Intuitive Surgical

People needed

59

Starts

2023-06-16

Expected to finish

2025-05-23

Last updated by the study team

2025-09-04

Who can join

Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSF — San Francisco, California, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• MSKCC — New York, New York, United States

Full record on ClinicalTrials.gov

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