IS-002 in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Phase 2 Multi-Center Randomized Controlled Feasibility Study of IS-002 in Subjects Undergoing Robotic-Assisted Radical Prostatectomy Using the da Vinci® Surgical System With Firefly® Fluorescence Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05946603
• Other study ID #: ISI-142325-2
• Status: Recruiting
• Phase: Phase 2
• Start date: June 16, 2023
• Est. completion date: April 1, 2026

Study information

• Verified date: December 2023
• Source: Intuitive Surgical
• Contact: Alina Lim
• Phone: 9259678697
• Email: info.is-002[@]intusurg.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 randomized controlled multi-center study of IS-002, in conjunction with near-infrared (NIR) fluorescence imaging, for identification of prostate cancer during robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using the da Vinci® X/Xi Surgical System with Firefly® Fluorescence Imaging.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria

1. Subjects aged 18 to 75.

2. Subject has a confirmed adenocarcinoma of the prostate as defined by (histo-) pathology.

3. Subject has CAPRA =6; or =T3 disease on imaging (TRUS and/or MRI); or a Gleason sum score =8; or regional lymphadenopathy suspicious for nodal metastases on imaging.

4. Subject is scheduled to undergo robotic-assisted radical prostatectomy (RARP) with (extended) pelvic lymph node dissection ((e)PLND) using a da Vinci® X/Xi Surgical System equipped with Firefly® Fluorescence Imaging.

5. Subject is willing and able to provide written informed consent.

6. Subject can comply with the study procedures and study visits and understands an informed consent document.

Exclusion criteria

1. Subject has known bone metastasis.

2. Subject has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

3. Subject has a known history of acute or chronic liver or kidney disease.

• Renal function at screening: i. Creatinine clearance: <50 mL/min as determined using the Cockcroft-Gault formula ii. Albumin: <LLN

• Hepatic function at screening: i. AST and/or ALT: >2.5x ULN ii. Total Bilirubin (serum): >1.5x ULN

4. Subject has received neo-adjuvant therapy, radiation therapy, focal ablation therapy, hormonal therapy, or androgen deprivation therapy within the last 4 months.

5. Subject is currently receiving an investigational therapeutic agent; or has participated in a study of an investigational therapeutic agent within the past 6 months prior to the day of IS-002 infusion; or is involved in a significant risk investigational device study within the past 6 months prior to the day of IS-002 infusion.

6. Subject has any other condition or personal circumstance that, in the judgment of the site Investigator, might interfere with the collection of complete quality data or represents an unacceptable safety profile.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Administration of IS-002
Intravenous administration of IS-002 approximately 24 hours prior to surgery

Device:
• Firefly fluorescent imaging
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002

Procedure:
• robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland
United States	MSKCC	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	UCSF	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
Primary	The proportion of subjects with =1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.	The proportion of subjects with =1 PSMs on final histopathologic assessment in the Intervention arm and the Control arm.	Within 3 months post-surgery
Primary	The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.	The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm.	Within 3 months post-surgery
Secondary	Diagnostic performance of IS-002 fluorescence	The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates.	Up to 1 year post-surgery
Secondary	Safety: Adverse event assessment	Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0	Up to 1 year post-surgery
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)	Area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration as calculated by linear up/log down trapezoidal method (AUC0-last)	Up to 24 hours post-IS-002 administration
Secondary	Time to biochemical recurrence (BCR)	Time to BCR in the Intervention arm and the Control arm. BCR is defined a PSA level >0.1 ng/mL as determined by an ultrasensitive PSA assay.	Up to 1 year post-surgery
Secondary	Time to secondary treatment initiation	Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm.	Up to 1 year post-surgery
Secondary	Number of intraoperative fluorescent lymph nodes that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only	In the Intervention arm, the number of intraoperative fluorescent lymph nodes, per subject and per lymph node basin, that are tumor positive that would not have been resected if the surgeon would have had access to white light imaging only.	Up to 3 months post surgery