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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574401
• Other study ID #: ISI-142325-1
• Status: Completed
• Phase: Phase 1
• Start date: October 10, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: October 2021
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• IS-002
Intravenous injection of IS-002 Investigational Drug

Locations

Country	Name	City	State
United States	UCSF Medical Center, Mission Bay	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology	30 days
Other	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.	An exploratory outcome measure of cancer fluorescent signal levels relative to normal tissue (tumor-to-background ratios) confirmed with gold standard histopathology	30 days
Primary	Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0	Number of participants treated with IS-002 with treatment-emergent adverse events as assessed by CTCAE v5.0	14 days
Secondary	IS-002 Maximum Plasma Concentration (Cmax)	Maximum Plasma Concentration (Cmax) of IS-002	-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Secondary	IS-002 Half-Life (t½)	Half-Life (t½) of IS-002	-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Secondary	IS-002 Clearance (CL)	Clearance (CL) of IS-002	-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours
Secondary	IS-002 Area Under the Plasma Concentration Versus Time Curve (AUC)	Area Under the Plasma Concentration Versus Time Curve (AUC) of IS-002	-5 minutes (pre-study drug), 5 minutes, 15 minutes, 30 minutes, 60 minutes, 2 hours, 4 hours, 6 hours, 24 hours