IS-002 in Prostate Cancer
Status
RECRUITING
Phase
PHASE2
Age
18 - 75 Years
Enrollments
60Conditions
Prostate CancerDrugs
Administration of IS-002Summary
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.
Locations
3 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Mohamad Allaf, MD
Status
- RECRUITING
Contact Person
- Matthew Tollefson, MD
Status
- RECRUITING
Contact Person
- James Eastham, MD
Eligibility Criteria
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:
• 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.
Study Plan
RARP + IS-002
SHAM_COMPARATOR
Subjects will receive IS-002, but during surgery NO fluorescence imaging will be performed.
DRUG:
Administration of IS-002Description:
Intravenous administration of IS-002 approximately 24 hours prior to surgeryPROCEDURE:
robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissectionDescription:
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
RARP + IS-002 + intraoperative near-infrared imaging
EXPERIMENTAL
Subjects will receive IS-002, and during surgery fluorescence imaging will be performed.
DRUG:
Administration of IS-002Description:
Intravenous administration of IS-002 approximately 24 hours prior to surgeryDEVICE:
Firefly fluorescent imagingDescription:
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002PROCEDURE:
robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissectionDescription:
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Outcome Measures
Primary Outcome Measures
The proportion of subjects with u22651 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
Secondary Outcome Measures
Diagnostic performance of IS-002 fluorescence
Safety: Adverse event assessment
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time to biochemical recurrence (BCR)
Time to secondary treatment initiation
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
Timeline
Last Updated
December 8, 2023Start Date
July 14, 2023Today
January 16, 2025Completion Date ( Estimated )
April 1, 2026
Sponsors of this trial
Lead Sponsor
Intuitive Surgical
RECRUITING 
21 - 64 Years