Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery

PRIMARY OBJECTIVES:

I. To determine the ability of indocyanine green (indocyanine green solution) (ICG) to
highlight pelvic lymphatic tissue with fluorescence during robot assisted radical
prostatectomy using near infrared fluorescence (diffuse optical imaging).

SECONDARY OBJECTIVES:

I. To evaluate the ability of this technique to improve lymph node yield, providing a
potential therapeutic benefit to these patients by removing additional lymph nodes that may
otherwise have been missed.

OUTLINE:

Patients receive indocyanine green transperineally and undergo diffuse optical imaging during
robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using
the da Vinci Robotic Surgical System.

After completion of study treatment, patients are followed up for 1-2 weeks.

Inclusion Criteria:

- Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer
with a prostate gland size =< 100 grams

- Intermediate risk: prostate specific antigen (PSA) between 10-20, Gleason grade
7, or clinical stage T2b

- High risk: PSA > 20 , Gleason grade >= 8, or clinical stage >= T2c

- Life expectancy of at least 10 years

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2

- The subject must be able to comply with the study procedures

- All subjects must have the ability to understand and the willingness to sign a written
informed consent

Exclusion Criteria:

- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal
liver function tests, as total bilirubin > 1.5 x normal

- Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal
liver function tests, as serum glutamic oxaloacetic transaminase (SGOT) > 2 x normal

- Prior prostate surgery (i.e. transurethral resection of the prostate), or any prior
abdominal or pelvic surgery, most specifically for surgeries that may have included
any form of lymphadenectomy or anatomic changes

- History of androgen deprivation therapy, any prior chemotherapy, or any prior
radiation therapy to the pelvis

- Subject has a previous history of adverse reaction or allergy to ICG, iodine,
shellfish or iodine dyes

- Subject in whom the use of x-ray dye or ICG is contraindicated including development
of adverse events when previously or presently administered

- Subject has any medical condition, which in the judgment of the investigator and/or
designee makes the subject a poor candidate for the investigational procedure

- The presence of medical conditions contraindicating general anesthesia or standard
surgical approaches