Summary

Eligibility
for males ages 18-75 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion

Description

Summary

This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.

Official Title

A Phase 1 Safety and Efficacy Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging

Keywords

Prostate Cancer Prostatic Neoplasms Dose escalation

Eligibility

You can join if…

Open to males ages 18-75

  • Subject is between the ages of 18 and 75.
  • Subject has a confirmed adenocarcinoma by histology of the prostate.
  • Subject has CAPRA > 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases
  • Subject is scheduled to undergo robotic prostatectomy with extended pelvic lymph node dissection (ePLND) using an da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.
  • Subject is willing and able to provide informed consent
  • Subject is considered capable of complying with study procedures and of understanding a written informed consent document.
  • Subject must be treatment naïve (not having received neo-adjuvant therapy, radiation therapy, hormonal therapy, androgen deprivation therapy within the last 4 months excluding Finasteride, Dutasteride, or other 5 alpha reductase inhibitors, or focal ablation techniques)

You CAN'T join if...

  • Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Subject is currently participating in and receiving study therapy or has participated in a study of an investigational agent within the past 6 months; is receiving study therapy or is involved in a significant risk investigational device study within the past 6 months
  • Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile
  • Subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy
  • Subject has a known history of acute or chronic liver or kidney disease

Location

  • UCSF Medical Center, Mission Bay
    San Francisco California 94158 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Intuitive Surgical
ID
NCT04574401
Phase
Phase 1
Study Type
Interventional
Last Updated