Clinical trial NCT05946603: IS-002 Phase 2 Prostate Cancer Study
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2023-07-14
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


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: \<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.

Primary outcomes:
measure: The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
timeFrame: Within 3 months post-surgery
measure: The mean number of positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm.
timeFrame: Within 3 months post-surgery
Secondary outcomes:
measure: Diagnostic performance of IS-002 fluorescence
timeFrame: Up to 1 year post-surgery
measure: Safety: Adverse event assessment
timeFrame: Up to 1 year post-surgery
measure: Pharmacokinetics: Area under the concentration-time curve (AUC)
timeFrame: Up to 24 hours post-IS-002 administration
measure: Time to biochemical recurrence (BCR)
timeFrame: Up to 1 year post-surgery
measure: Time to secondary treatment initiation
timeFrame: Up to 1 year post-surgery
measure: 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
timeFrame: Up to 3 months post surgery
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: MSKCC
state: New York
Study officials:
References: