Cytalux with Near Infrared Light for Intraoperative Imaging of Patients with Prostate Cancer Undergoing Surgery

Inclusion Criteria

• Provision of signed and dated informed consent and Health Insurance Portability and Accountability Act (HIPAA) form
• Male subjects 18 years of age and older
• Known primary prostate cancer
• Grade group 3 to 5 (≥ cT3) with either: * Suspected extraprostatic disease (EPD) (extracapsular extension [ECE] and/or seminal vesicle infiltration [SVI]), or 3 or more biopsy cores of grade group 3-5 * Suspected lymph node metastasis (clinical stage cN1, or by magnetic resonance imaging (mriN+), or by Prostate Specific Membrane Antigen positron emission tomography [PSMA PET+]) * Or both
• Planned to undergo a standard of care laparoscopic prostatectomy with or without robotic assistance, and lymph node dissection
• Ability to understand the requirements of the study and agree to abide by the study restrictions and to return for the required assessments
• Agree to stop folate or folic acid supplements at least 48 hours prior to injection of study agent

Exclusion Criteria

• The surgeon plans to perform an extraperitoneal approach
• Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
• History of anaphylactic reactions to products containing indocyanine green
• History of allergy to any of the components of pafolacianine