Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
To be eligible for this study, patients must meet all of the following criteria:
- Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0,
M0) without involvement of lymph nodes, bone, or visceral organs by CT or NM bone
scan. N1 by PSMA allowed with up to 3 LNs each ≤1 cm. If there is no frank bone
disease, but PSMA scan and CT scan are in discordance, then investigators will
discuss.
- Initial prostate biopsy, obtained within 3 months of enrollment, is available for
central pathologic review, and is confirmed to show at least 3 positive cores (at
least 1 core with at least 50% disease involvement with ≥4+3=7 disease) and a Gleason
sum of ≥8 (or 4+3=7 with at least 1 additional high-risk feature such as PSA>20 or
cT3)
- Radical prostatectomy has been scheduled
- 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 Enoblituzumab
(MGA271) until the time of prostatectomy.
Exclusion Criteria:
To be eligible for this study, patients should not meet any of the following criteria:
- Presence of known lymph node involvement on CT (N1 by PSMA allowed with up to 3 LNs
each ≤1 cm) or distant metastases by CT and NM bone scan
- 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 5?-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, with the exception of
patients who have been successfully treated for hepatitis B/C (i.e. documented
confirmation of cure at least 6 months after initial treatment).
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 1/16/24. Questions regarding updates should be directed to the study team contact.