Prostate Cancer
Conditions
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.
Interventions
DRUGIS-002
Intravenous injection of IS-002 Investigational Drug
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed