A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
Phase 1
Completed
- Conditions
- Prostate Cancer
- Interventions
- Drug: IS-002
- Registration Number
- NCT04574401
- Lead Sponsor
- Intuitive Surgical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 24
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)
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose escalation IS-002 Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 14 days Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0
- Secondary Outcome Measures
Name Time Method IS-002 Clearance (CL) -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours Clearance (CL) of IS-002
IS-002 Maximum Plasma Concentration (Cmax) -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours Maximum Plasma Concentration (Cmax) of IS-002
IS-002 Half-Life (t½) -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours Half-Life (t½) of IS-002
IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC) -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours Area Under the Plasma Concentration Versus Time Curve (AUC) of IS-002
Trial Locations
- Locations (1)
UCSF Medical Center, Mission Bay
🇺🇸San Francisco, California, United States