A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

Intuitive Surgical

Status and phase

Completed

Phase 1

Conditions

Prostate Cancer

Treatments

Drug: IS-002

Study type

Interventional

Funder types

Industry

Identifiers

NCT04574401

ISI-142325-1

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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