Clinical trial NCT04574401: A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
Official title: A Phase 1 Safety and Efficacy Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescent Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2020-10-05
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0
timeFrame: 14 days
Secondary outcomes:
measure: IS-002 Maximum Plasma Concentration (Cmax)
timeFrame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
measure: IS-002 Half-Life (t½)
timeFrame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
measure: IS-002 Clearance (CL)
timeFrame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
measure: IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC)
timeFrame: -5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Other outcomes:
measure: 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.
timeFrame: 30 days
measure: 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.
timeFrame: 30 days
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center, Mission Bay
state: California
Study officials:
References: