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Trial Title:
CYTALUX™for the Intraoperative Imaging of Prostate Cancer
NCT ID:
NCT06434909
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
fluorescent
image guided intervention
folate
prostate cancer
laparoscopic prostatectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Cytalux™ (pafolacianine) for fluorescent imaging
Description:
Cytalux™ (pafolacianine) injection: folate analog ligand conjugated with an indole
cyanine green-like dye for real-time cancer margin status.
This is used in conjunction with appropriate imaging system.
Arm group label:
Fluorescent guided surgery
Summary:
This study is being done to compare how much using Cytalux™ (pafolacianine) with NIR
(Near InfraRed) fluorescent imaging improves the detection of malignant (growing in an
uncontrolled way) tissue in adult subjects undergoing prostatectomy and lymph node
dissection for biopsy confirmed prostate cancer.
The U.S. Food and Drug Administration (FDA) has approved the targeted imaging agent
pafolacianine (Cytalux) for use in ovarian cancer (2021) and lung cancer surgery (2022.)
Detailed description:
This is an open label trial in up to 15 subjects with biopsy confirmed prostate cancer
(PCa) who have been scheduled to undergo a laparoscopic radical prostatectomy with or
without robotic assistance, with pelvic lymph node dissection. This is a non-intervention
trial to assess the accuracy of an imaging agent, folate targeted fluorescent dye
(pafolacianine), during a standard of care radical prostatectomy.
Qualifying subjects will be Grade Group 3 to 5 (>/= cT3) with either suspected
extraprostatic disease (EPD) (extracapsular extension (ECE) and/or seminal vesicle
infiltration (SVI)), or suspected lymph node metastasis (clinical stage cN1, or by
magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron
emission tomography (PSMA PET+).
Whether using an anterior or a posterior approach, the tissues planned for removal will
be visualized first under normal light, and their locations marked on a provided
template. All additional suspicious tissue or nodes will be similarly marked, whether
removed or not. Prior to removal, the field must be illuminated with Near Infrared light
(NIR) and fluorescent tissues must be marked on the template. This may proceed in an
iterative fashion, switching from first normal light to NIR as the surgical field
expands.
NIR imaging must be conducted in the timeframe of one hour to twenty-four hours following
IV infusion of pafolacianine. Lymphatics to be examined are, at a minimum, the external
iliac, internal iliac and obturator fossa, and common iliac. Fluorescence positive
nodules and nodes will be removed at the surgeon's discretion and sent as labeled
(specimen number, tissue, location) specimens to pathology without designation of
florescence. Ink dots should ideally be applied to the spot suspected of being cancerous.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Signed and dated informed consent form
2. Male subjects 18 years of age and older
3. Known primary prostate cancer
4. Grade Group 3 to 5 with either:
1. suspected extraprostatic disease (EPD) (extracapsular extension (ECE) and/or
seminal vesicle infiltration (SVI)), or 3 or more biopsy cores of grade group
3-5;
2. suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance
imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission
tomography (PSMA PET+));
3. or both.
5. Planned to undergo a laparoscopic prostatectomy with or without robotic assistance,
and lymph node dissection
6. Ability to understand the requirements of the study and agree to abide by the study
restrictions and to return for the required assessments
7. Agree to stop folate or folic acid supplements at least 48 hours prior to injection
of study agent
Exclusion Criteria:
1. The surgeon plans to perform an extraperitoneal approach
2. Any medical condition that in the opinion of the investigators could potentially
jeopardize the safety of the subject
3. History of anaphylactic reactions to products containing indocyanine green
4. History of allergy to any of the components of PAFOLACIANINE
Gender:
Male
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
IU Health Joe and Shelly Schwarz Cancer Center
Address:
City:
Carmel
Zip:
46032
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jennifer Lehman
Phone:
317-278-0340
Email:
jgeck@iu.edu
Investigator:
Last name:
Clinton Bahler, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University Health Melvin and Bren Simon Comprehensive Cancer Center
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Lehman
Phone:
317-278-0340
Email:
jgeck@iu.edu
Investigator:
Last name:
Clinton Bahler, MD
Email:
Principal Investigator
Facility:
Name:
Indiana University Health Methodist Hospital
Address:
City:
Indianapolis
Zip:
46202
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Jennifer Lehman
Phone:
317-278-0340
Email:
jgeck@iu.edu
Investigator:
Last name:
Clinton Bahler, MD
Email:
Principal Investigator
Start date:
September 19, 2024
Completion date:
October 2025
Lead sponsor:
Agency:
Indiana University
Agency class:
Other
Collaborator:
Agency:
On Target Laboratories, LLC
Agency class:
Industry
Source:
Indiana University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06434909
