A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy
NCT ID: NCT04574401
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2020-10-10
2021-09-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
OTHER
NONE
Study Groups
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Dose escalation
Dose-cohort escalation of a single intravenous injection of IS-002 at four different dose levels
IS-002
Intravenous injection of IS-002 Investigational Drug
Interventions
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IS-002
Intravenous injection of IS-002 Investigational Drug
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
MALE
No
Sponsors
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Intuitive Surgical
INDUSTRY
Responsible Party
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Locations
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UCSF Medical Center, Mission Bay
San Francisco, California, United States
Countries
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Other Identifiers
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ISI-142325-1
Identifier Type: -
Identifier Source: org_study_id