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

Intuitive Surgical24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

IS-002DRUG

Intravenous injection of IS-002 Investigational Drug

Eligibility

Sex: MALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

UCSF Medical Center, Mission Bay

San Francisco, California, United States

Outcomes

Primary Outcomes

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

Time frame: 14 days

Secondary Outcomes

IS-002 Maximum Plasma Concentration (Cmax)

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

IS-002 Half-Life (t½)

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

IS-002 Clearance (CL)

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

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

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

Data from ClinicalTrials.gov

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