Study on IS-002 for Detecting Prostate Cancer During Robotic Surgery

Sponsor: Intuitive Surgical

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05946603

Provider View

This clinical trial is testing a new method using IS-002 and special imaging technology to help identify prostate cancer during robotic surgery. The study aims to improve the detection of cancerous tissues in patients undergoing prostate removal and lymph node dissection.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of a new approach using IS-002 combined with near-infrared (NIR) fluorescence imaging to identify prostate cancer during robotic-assisted surgery. This method is being tested in patients undergoing a procedure to remove the prostate and nearby lymph nodes using advanced robotic technology. The goal is to enhance the surgeon's ability to detect cancerous tissues during the operation.

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.

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