Back to resultsIS-002 in Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Administration of IS-002
Firefly fluorescent imaging
robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Sponsored by
About this trial
This is an interventional other trial for Prostate Cancer
Eligibility Criteria
Inclusion criteria Subjects aged 18 to 75. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology. 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. 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. Subject is willing and able to provide written informed consent. Subject can comply with the study procedures and study visits and understands an informed consent document. Exclusion criteria Subject has known bone metastasis. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. 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 Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months. 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. 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.
Sites / Locations
- UCSFRecruiting
- Johns HopkinsRecruiting
- Mayo Clinic
- MSKCC
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
RARP + IS-002
RARP + IS-002 + intraoperative near-infrared imaging
Arm Description
Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.
Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Diagnostic performance of IS-002 fluorescence
The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.
Safety: Adverse event assessment
Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0
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)
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.
Time to secondary treatment initiation
Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05946603
Brief Title
IS-002 in Prostate Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RARP + IS-002
Arm Type
Sham Comparator
Arm Description
Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.
Arm Title
RARP + IS-002 + intraoperative near-infrared imaging
Arm Type
Experimental
Arm Description
Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.
Intervention Type
Drug
Intervention Name(s)
Administration of IS-002
Intervention Description
Intravenous administration of IS-002 approximately 24 hours prior to surgery
Intervention Type
Device
Intervention Name(s)
Firefly fluorescent imaging
Intervention Description
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002
Intervention Type
Procedure
Intervention Name(s)
robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Other Intervention Name(s)
RARP
Intervention Description
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Primary Outcome Measure Information:
Title
The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
Description
The proportion of subjects with ≥1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
Time Frame
Within 3 months post-surgery
Title
The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
Description
The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.
Time Frame
Within 3 months post-surgery
Secondary Outcome Measure Information:
Title
Diagnostic performance of IS-002 fluorescence
Description
The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.
Time Frame
Up to 1 year post-surgery
Title
Safety: Adverse event assessment
Description
Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0
Time Frame
Up to 1 year post-surgery
Title
Pharmacokinetics: Area under the concentration-time curve (AUC)
Description
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)
Time Frame
Up to 24 hours post-IS-002 administration
Title
Time to biochemical recurrence (BCR)
Description
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.
Time Frame
Up to 1 year post-surgery
Title
Time to secondary treatment initiation
Description
Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.
Time Frame
Up to 1 year post-surgery
Title
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
Description
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.
Time Frame
Up to 3 months post surgery
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria
Subjects aged 18 to 75.
Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.
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.
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.
Subject is willing and able to provide written informed consent.
Subject can comply with the study procedures and study visits and understands an informed consent document.
Exclusion criteria
Subject has known bone metastasis.
Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
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
Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nynke van den Berg, PhD
Phone
6503347015
Email
nynke.vandenberg@intusurg.com
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Nguyen, MD
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamad Allaf, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Tollefson, MD
Facility Name
MSKCC
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Eastham, MD
12. IPD Sharing Statement
Learn more about this trial
IS-002 in Prostate Cancer
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