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Trial of Enoblituzumab for High-Risk Localized Prostate Cancer

This study is testing a new approach for men with high-risk localized prostate cancer. It compares a drug called enoblituzumab given before surgery to the standard surgery alone. Enoblituzumab is given through an IV (into the vein) every two weeks for 12 weeks before a radical prostatectomy (surgery to remove the prostate). The study wants to see if enoblituzumab can prevent the cancer from coming back after surgery. You may be eligible if you are a man aged 18 or older with high-risk localized prostate cancer that has not spread to other organs. The main goal is to measure how many men remain cancer-free three years after surgery. The current recruitment status is unclear.

Study design
This is a multi-center, randomized study with 219 planned participants. Patients will be randomly assigned to receive either enoblituzumab or standard of care.
What's involved
Participants will receive enoblituzumab infusions every two weeks for 12 weeks, followed by radical prostatectomy. You will also have a pre-treatment prostate biopsy and imaging tests.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for recurrence-free survival for 3 years after prostatectomy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06014255

Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~219 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:EnoblituzumabStandard of Care

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recurrence-free survival (RFS)
Measured over 3 years post-prostatectomy

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

5 sites across 4 states
Minnesota2
Illinois1
Maryland1
Nebraska1

Study leadership

  • Eugene Shenderov · PRINCIPAL_INVESTIGATOR · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 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, 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).

What this trial measures

  • Recurrence-free survival (RFS)3 years post-prostatectomy

    Number of participants with RFS, defined as from randomization to any metastasis events, pelvic lymph node recurrence, detectable prostate-specific antigen (PSA) (PSA \>= 0.2 ng/mL, confirmed by a second PSA of the same level or higher), or start of salvage or adjuvant therapy based on PSA criteria of 0.1 ng/mL or higher, or death for any cause, whichever occurs first.