A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dose escalation Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels |
Drug: IS-002
Intravenous injection of IS-002 Investigational Drug
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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
Other Outcome Measures
- The number of subjects with above-background IS-002 fluorescent signal observed on the prostate surface that is confirmed as a positive surgical margin through pathological confirmation of malignant tissue via hematoxylin and eosin stain. [30 days]
An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology
- The number of lymph nodes with IS-002 fluorescent signal that contain metastatic disease as confirmed through pathological confirmation of malignant tissue via hematoxylin and eosin stain. [30 days]
An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is between the ages of 18 and 75.
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Subject has a confirmed adenocarcinoma by histology of the prostate.
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Subject has CAPRA > 6, or T3 a or b disease on imaging (TRUS and/or MRI), or regional lymphadenopathy suspicious for nodal metastases
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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.
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Subject is willing and able to provide informed consent
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Subject is considered capable of complying with study procedures and of understanding a written informed consent document.
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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:
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Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
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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
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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
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Subject has a known history of bone metastasis documented on the basis of bone scans and/or biopsy
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Subject has a known history of acute or chronic liver or kidney disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UCSF Medical Center, Mission Bay | San Francisco | California | United States | 94158 |
Sponsors and Collaborators
- Intuitive Surgical
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ISI-142325-1