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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Administration of IS-002; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection; Device: Firefly fluorescent imaging

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • UCSF
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10065
      • MSKCC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: RARP + IS-002; Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.	Drug: Administration of IS-002; Intravenous administration of IS-002 approximately 24 hours prior to surgery; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection; Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection; Other Names: RARP
Experimental: RARP + IS-002 + intraoperative near-infrared imaging; Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.	Drug: Administration of IS-002; Intravenous administration of IS-002 approximately 24 hours prior to surgery; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection; Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection; Other Names: RARP; Device: Firefly fluorescent imaging; Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic performance of IS-002 fluorescence	The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.	Up to 1 year post-surgery
Safety: Adverse event assessment	Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0	Up to 1 year post-surgery
Pharmacokinetics: Area under the concentration-time curve (AUC)	Area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration as calculated by linear up/log down trapezoidal method (AUC0-last)	Up to 24 hours post-IS-002 administration
Time to biochemical recurrence (BCR)	Time to BCR in the Intervention arm and the Control arm. BCR is defined a PSA level >0.1 ng/mL as determined by an ultrasensitive PSA assay.	Up to 1 year post-surgery
Time to secondary treatment initiation	Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.	Up to 1 year post-surgery
Number of intraoperative fluorescent lymph nodes that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only	In the Intervention arm, the number of intraoperative fluorescent lymph nodes, per subject and per lymph node basin, that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only.	Up to 3 months post surgery

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): May 21, 2024
• Study Completion (Actual): May 23, 2025

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorophosphate
• Other Study ID Numbers: ISI-142325-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No