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IS-002 Phase 2 Prostate Cancer Study

NCT05946603 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2025-09-04

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2024-05-21
Completion
2025-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946603 on ClinicalTrials.gov