Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer

PRIMARY OBJECTIVES: I. Determine the preferred imaging dose (if any), based on image quality
and correlation with pathological findings, of intravenously administered MDX1201-A488 in a
dose-escalating study (doses of 5 and 15 mg) in patients with moderate to high-risk prostate
cancer prior to undergoing robotic assisted laparoscopic prostatectomy (RALP), subject to
predetermined safety stopping rules.

SECONDARY OBJECTIVES: I. Correlate intra-operative optical imaging (IOOI) findings with
pre-operative magnetic resonance imaging (MRI) findings and clinical staging.

OUTLINE: This is a dose-escalation study. Patients receive anti-PSMA monoclonal antibody
MDX1201-A488 intravenously (IV) over 30 minutes on day 1 and undergo IOOI during RALP on day
5.

After completion of study treatment, patients are followed up at 4-7 weeks, 3 months, 6
months, 9 months, and 1 year.

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the prostate; patients with small cell,
neuroendocrine, and transitional cell carcinomas are not eligible

- Patients being considered for RALP and pelvic lymphadenectomy with life expectancy
greater than 10 years as determined by treating physician

- Patients with moderate to high-risk disease as defined by D' Amico risk stratification
and having at least one of the following:

- Prostate-specific antigen (PSA) level > 10 ng/ml

- Gleason score >= 7

- Clinical stage >= T2c

- Any performance status on the Eastern Cooperative Oncology Group (ECOG)

- Men must agree to use adequate contraception (hormonal or barrier method of birth
control or abstinence) prior to study entry and for six months following duration of
study participation

- Bone scan without evidence of skeletal metastases

- Skeletal x-ray film or MRI confirmation of absent skeletal metastases if bone scan
findings are equivocal

- 3Tesla (T) multiparametric MRI of the prostate performed at City of Hope (COH) within
6 week time period prior to surgery; MRI without evidence of bladder neck involvement,
rectal wall involvement, or pelvic lymphadenopathy with no nodes > 1 cm

- White blood cell (WBC) within normal limits

- Hemoglobin (hgb) > 10 G/dL

- Platelet count (PLT) > 100 K/uL

- Creatinine clearance within normal limits

- Serum glutamic oxaloacetic transaminase (SGOT) < 1.5 x upper limit of normal (ULN)

- Serum glutamate pyruvate transaminase (SGPT) < 1.5 x ULN

- Bilirubin < 1.5 x ULN

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

Exclusion Criteria:

- Patients should not have any uncontrolled illness including ongoing or active
infection

- Prior treatment of prostate cancer including brachytherapy, radiation therapy,
cryosurgery, high-intensity focused ultrasound (HIFU), or vaccine therapy

- Prior pelvic surgery or radiation

- Urinary incontinence requiring condom catheter use or >= 1 pad/day

- Prior anti-incontinence surgery

- Use of neoadjuvant hormonal manipulation

- History of active co-existing non-prostatic malignancies except basal cell skin cancer
or squamous cell skin cancer

- Subjects, who in the opinion of the investigator, may not be able to comply with the
safety monitoring requirements of the study