Can a Pre-Surgery antibody boost prostate cancer outcomes?
NCT ID NCT02923180
First seen Aug 21, 2026 · Last updated Aug 21, 2026
Summary
This trial is testing whether giving an experimental drug called enoblituzumab before prostate removal surgery can help fight prostate cancer. Men with intermediate- or high-risk localized prostate cancer will receive the drug weekly for six weeks before their scheduled surgery. The study aims to see if the drug is safe and whether it can reduce the chance of cancer returning after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enoblituzumab (MGA271), an experimental antibody given intravenously before prostate removal surgery
- What this could lead to
- If effective, this approach could reduce the risk of prostate cancer returning after surgery, potentially pointing toward a new treatment strategy for high-risk patients.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The drug may cause side effects, and it is unclear if it will improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
33 people
The number who actually took part.
- Started
-
Feb 2017
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21205, United States
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Other studies related to the condition(s) this trial covers.
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