Clinical Research Directory

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