Prostate Cancer
Conditions
Keywords
fluorescent, image guided intervention, folate, prostate cancer, laparoscopic prostatectomy
Brief 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.
Interventions
DRUGCytalux™ (pafolacianine) for fluorescent imaging
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.
PROCEDUREImage Guided Surgery
prostatectomy using appropriate imaging system
Sponsors
Indiana University
On Target Laboratories, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Signed and dated informed consent form and HIPAA form 2. Male subjects 18 years of age and older 3. Known primary prostate cancer 4. Grade Group 3 to 5 (≥cT3) 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 standard of care 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of residual cancer | Day of surgery (visit 2) | The proportion of subjects who have a Clinically Significant Event (CSE). A CSE is a composite endpoint defined as at least one of the following outcomes: 1. One or more resected "NIR only" positive lymph nodes that contain metastatic disease as confirmed by pathology. 2. Histologically confirmed cancer in resected "NIR only" residual non-nodal soft tissue following prostatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment change | Day of surgery (visit 2) | To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of PAFOLACIANINE with NIR imaging. |
| Differences in sensitivity and specificity of lesions | Day of surgery (visit 2) | T evaluate proportion of lesions that are either: fluorescence positive, and prostate cancer positive; fluorescence positive but cancer negative; fluorescence negative but cancer positive; or, fluorescence negative and cancer negative. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClinton Bahler, MD
Indiana University
Outcome results
None listed