Neoadjuvant Enoblituzumab (MGA271) in Men With Localized Intermediate and High-Risk Prostate Cancer

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs
Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥7
Radical prostatectomy has been scheduled at Johns Hopkins Hospital
Age ≥18 years
ECOG performance status 0-1, or Karnofsky score ≥ 70% (see Appendix A)

Adequate bone marrow, hepatic, and renal function:

WBC >3,000 cells/mm3
ANC >1,500 cells/mm3
Hemoglobin >9.0 g/dL
Platelet count >100,000 cells/mm3
Serum creatinine <1.5 × upper limit of normal (ULN)
Serum bilirubin <1.5 × ULN
ALT <3 × ULN
AST <3 × ULN
Alkaline phosphatase <3 × ULN
The etiology of abnormal bilirubin and transaminase levels should be evaluated prior to study entry.
Willingness to provide written informed consent and HIPAA authorization for the release of personal health information, and the ability to comply with the study requirements (note: HIPAA authorization will be included in the informed consent)
Willingness to use barrier contraception from the time of first dose of MGA271 until the time of prostatectomy.

Exclusion Criteria:

Presence of known lymph node involvement or distant metastases
Other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors
Prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer
Prior immunotherapy/vaccine therapy for prostate cancer
Prior use of experimental agents for prostate cancer
Concomitant treatment with other hormonal therapy or 5α-reductase inhibitors
Current use of systemic corticosteroids or use of systemic corticosteroids within 4 weeks of enrollment (inhaled corticosteroids for asthma or COPD are permitted as are other non-systemic steroids such as topical corticosteroids)
History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjögren syndrome, and sarcoidosis)
History of malignancy within the last 3 years, with the exception of non-melanoma skin cancers and superficial bladder cancer
Uncontrolled major active infectious, cardiovascular, pulmonary, hematologic, or psychiatric illnesses that would make the patient a poor study candidate
Known prior or current history of HIV and/or hepatitis B/C