A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IS-002
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
- UCSF Medical Center, Mission Bay
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dose escalation
Arm Description
Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels
Outcomes
Primary Outcome Measures
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
Secondary Outcome Measures
IS-002 Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax) of IS-002
IS-002 Half-Life (t½)
Half-Life (t½) of IS-002
IS-002 Clearance (CL)
Clearance (CL) of IS-002
IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve (AUC) of IS-002
Full Information
NCT ID
NCT04574401
First Posted
September 15, 2020
Last Updated
October 21, 2021
Sponsor
Intuitive Surgical
1. Study Identification
Unique Protocol Identification Number
NCT04574401
Brief Title
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 10, 2020 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intuitive Surgical
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose escalation
Arm Type
Experimental
Arm Description
Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels
Intervention Type
Drug
Intervention Name(s)
IS-002
Intervention Description
Intravenous injection of IS-002 Investigational Drug
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
Description
Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
Time Frame
14 days
Secondary Outcome Measure Information:
Title
IS-002 Maximum Plasma Concentration (Cmax)
Description
Maximum Plasma Concentration (Cmax) of IS-002
Time Frame
-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Title
IS-002 Half-Life (t½)
Description
Half-Life (t½) of IS-002
Time Frame
-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Title
IS-002 Clearance (CL)
Description
Clearance (CL) of IS-002
Time Frame
-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Title
IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC)
Description
Area Under the Plasma Concentration Versus Time Curve (AUC) of IS-002
Time Frame
-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Other Pre-specified Outcome Measures:
Title
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.
Description
An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology
Time Frame
30 days
Title
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.
Description
An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology
Time Frame
30 days
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
UCSF Medical Center, Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
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