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Trial Title:
IS-002 in Prostate Cancer
NCT ID:
NCT05946603
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Fluorophosphate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Administration of IS-002
Description:
Intravenous administration of IS-002 approximately 24 hours prior to surgery
Arm group label:
RARP + IS-002
Arm group label:
RARP + IS-002 + intraoperative near-infrared imaging
Intervention type:
Device
Intervention name:
Firefly fluorescent imaging
Description:
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence
imaging of IS-002
Arm group label:
RARP + IS-002 + intraoperative near-infrared imaging
Intervention type:
Procedure
Intervention name:
robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Description:
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node
dissection
Arm group label:
RARP + IS-002
Arm group label:
RARP + IS-002 + intraoperative near-infrared imaging
Other name:
RARP
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.
Criteria for 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: 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
UCSF
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Enrolling by invitation
Facility:
Name:
Johns Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Mohamad Allaf, MD
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Matthew Tollefson, MD
Email:
Principal Investigator
Facility:
Name:
MSKCC
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Investigator:
Last name:
James Eastham, MD
Email:
Principal Investigator
Start date:
June 16, 2023
Completion date:
April 1, 2026
Lead sponsor:
Agency:
Intuitive Surgical
Agency class:
Industry
Source:
Intuitive Surgical
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05946603
