Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated
with Desferroxamine and radiolabeled with 89Zr. [89Zr]-Df-IAB2M targets the extracellular
domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic
prostate cancer lesions.

[111In]-capromab pendetide (Prostascint®) is an FDA approved imaging agent targeting the
intracellular domain of PSMA. It is anticipated that [89Zr]-Df-IAB2M will outperform
Prostascint® because of this targeting difference.

Inclusion Criteria:

Patients must meet ALL criteria listed below for entry:

- Age ≥ 18 years

- Signed, written IRB-approved informed consent

- Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a
candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x-ray,
CT scan or MRI) who are at high-risk for pelvic lymph node metastases.

- High Risk defined as:

- Gleason score ≥ 8 or

- Gleason 4+3 with a PSA > 10 or

- PSA > 20 ng/mL or

- T3a

- Patients scheduled for a [111In]-capromab pendetide scan or had a recent
[111In]-capromab pendetide scan within 28 days of screening visit or would be willing
to undergo a [111In]-capromab pendetide scan

- Karnofsky Performance status of ≥ 60

- Life expectancy of at least 6 months

- Patients with any previous history of another malignancy (other than in-situ cancer,
basal or squamous cell skin cancer) must be disease free for a period of three years.

- Acceptable liver function:

- Bilirubin ≤ 1.5 times upper limit of normal or <3 x ULN for patients with
Gilbert's disease

- AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of
normal (if liver metastases are present, then ≤ 5 x ULN is allowed)

- Acceptable renal function:

- Serum creatinine within normal limits, OR

- calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine
levels above institutional normal.

- Acceptable hematologic status:

- Granulocyte ≥ 1500 cells/mm3

- Platelet count ≥ 150,000 (plt/mm3)

- Hemoglobin ≥ 9 g/dL

- For men of child-producing potential, the use of effective contraceptive methods
during the study

Exclusion Criteria:

Patients will be excluded from entry if ANY of the criteria listed below are met:

- New York Heart Association Class III or IV, cardiac disease, myocardial infarction
within the past 6 months

- Unstable arrhythmia, or evidence of ischemia on ECG

- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy

- Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy
for prostate cancer.

- Unwillingness or inability to comply with procedures required in this protocol

- Known infection with HIV, hepatitis B, or hepatitis C

- Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions)
that could compromise protocol objectives in the opinion of the investigator and/or
the sponsor

- Previous [111In]-capromab pendetide image test