IS-002 Phase 2 Prostate Cancer Study

NCT ID: NCT05946603

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-16
• Study Completion Date: 2025-05-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RARP + IS-002

Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.

Group Type: SHAM_COMPARATOR

Administration of IS-002

Intervention Type: DRUG

Intravenous administration of IS-002 approximately 24 hours prior to surgery

robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Intervention Type: PROCEDURE

Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

RARP + IS-002 + intraoperative near-infrared imaging

Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.

Group Type: EXPERIMENTAL

Administration of IS-002

Intervention Type: DRUG

Intravenous administration of IS-002 approximately 24 hours prior to surgery

Firefly fluorescent imaging

Intervention Type: DEVICE

Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002

robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Intervention Type: PROCEDURE

Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Interventions

Administration of IS-002

Intravenous administration of IS-002 approximately 24 hours prior to surgery

Intervention Type: DRUG

Firefly fluorescent imaging

Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002

Intervention Type: DEVICE

robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Intervention Type: PROCEDURE

Other Intervention Names

RARP

Eligibility Criteria

Inclusion Criteria

1. Subjects aged 18 to 75.

2. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.

3. 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.

4. 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.

5. Subject is willing and able to provide written informed consent.

6. Subject can comply with the study procedures and study visits and understands an informed consent document.

Exclusion Criteria

1. Subject has known bone metastasis.

2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

3. 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

4. Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.

5. 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.

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

ISI-142325-2

Identifier Type: -

Identifier Source: org_study_id