Prostate Cancer
Conditions
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.
Interventions
DRUGAdministration of IS-002
Intravenous administration of IS-002 approximately 24 hours prior to surgery
DEVICEFirefly fluorescent imaging
Near-infrared fluorescence imaging using Firefly technology will allow fluorescence imaging of IS-002
PROCEDURErobotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Subject will undergo robotic-assisted laparoscopic prostatectomy with pelvic lymph node dissection
Sponsors
Intuitive Surgical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with ≥1 positive surgical margins (PSMs) on final histopathologic assessment in the Intervention arm and the Control arm. | Within 3 months post-surgery | The proportion of subjects with ≥1 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. | Within 3 months post-surgery | The mean number of PSMs on final histopathologic assessment in the Intervention arm and the Control arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: Area under the concentration-time curve (AUC) | Up to 24 hours post-IS-002 administration | 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) |
| Time to biochemical recurrence (BCR) | Up to 1 year post-surgery | 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. |
| Diagnostic performance of IS-002 fluorescence | Up to 1 year post-surgery | The key secondary outcome is the determination of false-positive, true-positive, false-negative and true-negatives rates. |
| 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 | Up to 3 months post surgery | 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. |
| Time to secondary treatment initiation | Up to 1 year post-surgery | Time to secondary treatment(s) for prostate cancer in the Intervention arm and the Control arm. |
| Safety: Adverse event assessment | Up to 1 year post-surgery | Incidence of treatment-emergent adverse events from time of IS-002 administration through study exit using CTCAE v5.0 |
Countries
United States
Outcome results
None listed