IS-002 Phase 2 Prostate Cancer Study

NCT05946603 | Completed Phase 2 FDA Drug

• 1 other identifier: ISI-142325-2
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.

  The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.

  Within 3 months post-surgery

• The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.

  The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.

  Within 3 months post-surgery

Secondary Outcomes (6)

• Diagnostic performance of IS-002 fluorescence

  Up to 1 year post-surgery

• Safety: Adverse event assessment

  Up to 1 year post-surgery

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  Up to 24 hours post-IS-002 administration

• Time to biochemical recurrence (BCR)

  Up to 1 year post-surgery

• Time to secondary treatment initiation

  Up to 1 year post-surgery

Study Arms (2)

RARP + IS-002

SHAM COMPARATOR

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

Drug: Administration of IS-002; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

RARP + IS-002 + intraoperative near-infrared imaging

EXPERIMENTAL

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

Drug: Administration of IS-002; Device: Firefly fluorescent imaging; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Interventions

Administration of IS-002 DRUG

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

RARP + IS-002; RARP + IS-002 + intraoperative near-infrared imaging

Firefly fluorescent imaging DEVICE

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

RARP + IS-002 + intraoperative near-infrared imaging

robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection PROCEDURE

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

Also known as: RARP

RARP + IS-002; RARP + IS-002 + intraoperative near-infrared imaging

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (4)

UCSF

San Francisco, California, 94158, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MSKCC

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 14, 2023
• Study Start: June 16, 2023
• Primary Completion: May 21, 2024
• Study Completion: May 23, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)