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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
59
Intravenous administration of IS-002 approximately 24 hours prior to surgery
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
UCSF
San Francisco, California, United States
Johns Hopkins
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
MSKCC
New York, New York, United States
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.
Time frame: Within 3 months post-surgery
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.
Time frame: Within 3 months post-surgery
Diagnostic performance of IS-002 fluorescence
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
Safety: Adverse event assessment
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
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 frame: Up to 24 hours post-IS-002 administration
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 frame: Up to 1 year post-surgery
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Time to secondary treatment initiation
Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.
Time frame: Up to 1 year post-surgery
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.
Time frame: Up to 3 months post surgery