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NCT Number: NCT04574401

A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

UCSF Medical Center, Mission Bay

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

IS-002

Drug

Intravenous injection of IS-002 Investigational Drug

Primary outcomes

  1. Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0

    Time frame: 14 days

    Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0

Secondary outcomes

  1. IS-002 Maximum Plasma Concentration (Cmax)

    Time frame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours

    Maximum Plasma Concentration (Cmax) of IS-002

  2. IS-002 Half-Life (t½)

    Time frame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours

    Half-Life (t½) of IS-002

  3. IS-002 Clearance (CL)

    Time frame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours

    Clearance (CL) of IS-002

  4. IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC)

    Time frame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours

    Area Under the Plasma Concentration Versus Time Curve (AUC) of IS-002

Other outcomes

  1. The number of subjects with above-background IS-002 fluorescent signal observed on the prostate surface that is confirmed as a positive surgical margin through pathological confirmation of malignant tissue via hematoxylin and eosin stain.

    Time frame: 30 days

    An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology

  2. The number of lymph nodes with IS-002 fluorescent signal that contain metastatic disease as confirmed through pathological confirmation of malignant tissue via hematoxylin and eosin stain.

    Time frame: 30 days

    An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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