IS-002 in Prostate Cancer

Phase 2

Recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: Administration of IS-002; Procedure: robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection; Device: Firefly fluorescent imaging

• Registration Number: NCT05946603
• Lead Sponsor: Intuitive Surgical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-16
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-07
• Study First Posted: 2023-07-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RARP + IS-002	Administration of IS-002	Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.
RARP + IS-002	robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection	Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.
RARP + IS-002 + intraoperative near-infrared imaging	Administration of IS-002	Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.
RARP + IS-002 + intraoperative near-infrared imaging	Firefly fluorescent imaging	Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.
RARP + IS-002 + intraoperative near-infrared imaging	robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection	Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.	Within 3 months post-surgery	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.	Within 3 months post-surgery	The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.

Secondary Outcome Measures

Name	Time	Method
Safety: Adverse event assessment	Up to 1 year post-surgery	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)	Up to 24 hours post-IS-002 administration	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)
Diagnostic performance of IS-002 fluorescence	Up to 1 year post-surgery	The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.
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	Up to 3 months post surgery	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 to biochemical recurrence (BCR)	Up to 1 year post-surgery	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	Up to 1 year post-surgery	Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.

Trial Locations

Locations (4)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

UCSF; 🇺🇸 San Francisco, California, United States

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

MSKCC; 🇺🇸 New York, New York, United States