MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

This is an open-label, multi-center, single-dose study of AuroLase Therapy in the focal
ablation of neoplastic prostate tissue via nanoparticle directed irradiation. The patient
population consists of men with low to intermediate risk localized prostate cancer with MRI
visible and confirmed focal areas of prostate cancer using MR US Fusion Guided Biopsy. The
patient also has no disease detected via ultrasound guided biopsy outside of areas visualized
on MR imaging.There is one arm/group to this study: Up to forty five (45) patients will
receive a single intravenous infusion of AuroShell particles 12 to 36 hours prior to MRI/US
guided laser irradiation using an FDA cleared laser and an interstitial optical fiber.

Efficacy and acute volume of ablation will be assessed by contrast-enhanced MRI 48 - 96 hours
after laser illumination to allow time for the appearance of coagulative necrosis and prior
to reconfiguration of tissue by lytic action. An appearance of a 'void' on MRI would be more
generally expected than lesion shrinkage. Efficacy of focal ablation of prostate tissue will
be assessed by MRI /Ultrasound guided biopsy at 3 months (primary endpoint) and again at 1
year after laser treatment. Per standard of care patient follow up will continue on a 6 month
basis beyond the one year follow up but will be outside the scope of the study.

Inclusion Criteria:

- Patients must have documented histological or cytological evidence of tumor(s) of the
prostate.

- Patients must be ≥ 45 years of age

- Patients or their legal representative must be able to read, understand and sign an
informed consent

- Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR
imaging

- Prostate cancer is diagnosed by MR image guided biopsies

- Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided
prostate biopsy.

- If the standard biopsy cores are positive, they must be from the same location in the
prostate as MR lesion was biopsied and proven to be cancerous. (Left / Right, Base,
Mid Gland, Apex).

- Prior MRI results dated within 120 days prior to ablation.

- No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to
r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10

- PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml

- The patient has given written informed consent after the nature of the study and
alternative treatment options have been explained

Exclusion Criteria:

- Patients with known hypersensitivity to any of the components of the PEGylated
AuroShell suspension (polyethylene glycol, gold)

- Patients who are receiving concurrent investigational therapy or who have received
investigational therapy within a period of 5 half-lives of the investigational therapy
in question prior to the day of dosing with the PEGylated AuroShell particles
(investigational therapy is defined as treatment for which there is currently no
regulatory authority approved indication)

- Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC
(101.3 ºF) within 3 days of the first scheduled day of dosing

- Any other medical condition, including mental illness or substance abuse, deemed by
the Investigator to be likely to interfere with a patient's ability to sign informed
consent, cooperate and participate in the study, or interfere with the interpretation
of the results.

- The presence of 3 or more MR Visible lesions positive on biopsy.

- The presence of extra capsular, seminal vesicle invasion or metastatic disease.

- Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted
device; claustrophobia; inability to tolerate rectal coil, etc…)

- Patient with inability to follow up.

- History of prior treatment for prostate cancer.

- Acute urinary tract infection.

- Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) >
20

- Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30
are excluded, due to they will not be able to undergo gadolinium enhance MRI.

- Patients with acute or chronic hepatic dysfunction as evidenced by clinically
significant abnormalities in albumin, total protein, or prothrombin time, or evidence
of hepatic injury with clinically important (> grade 1) changes in AST, ALT, ALP,
bilirubin, or GGT values.

- Patients with uncontrolled coagulopathies who are at increased risk of bleeding.

- Altered mental status preventing consent or answering questions during conduct of the
trial will be excluded for safety purposes.

- Other medical or surgical conditions, especially involving the cardiac, respiratory,
renal or hepatic organ systems that would either be unsafe for the patient, would
limit study participation, or that would impede the determination of causality of any
adverse events experienced during the conduct of this study.