NCT05946603

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 Firefly® Fluorescence Imaging.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Administration of IS-002	Intravenous administration of IS-002 approximately 24 hours prior to surgery
DEVICE	Firefly fluorescent imaging	Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002
PROCEDURE	robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection	Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Timeline

• Start date: 2023-06-16
• Primary completion: 2024-05-21
• Completion: 2025-05-23
• First posted: 2023-07-14
• Last updated: 2025-09-04

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study