Actively Recruiting
Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer
Led by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Updated on 2025-10-29
219
Participants Needed
5
Research Sites
262 weeks
Total Duration
On this page
Sponsors
S
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead Sponsor
M
MacroGenics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study evaluates the efficacy, anti-tumor effect, and immunogenicity of neoadjuvant enoblituzumab given before radical prostatectomy. Patients will be randomized to enoblituzumab for a total of 12 weeks beginning 84 days before radical prostatectomy or standard of care arms.
CONDITIONS
Official Title
Trial of Neoadjuvant Enoblituzumab vs SOC in Men With High-Risk Localized Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 years or older
- Histologically confirmed adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0 without lymph node, bone, or visceral involvement by CT or bone scan (N1 by PSMA allowed with up to 3 lymph nodes 3 cm)
- Initial prostate biopsy within 3 months before enrollment showing at least 3 positive cores, with at least 1 core having 1 50% disease involvement and Gleason score 8 (or 4+3=7 with additional high-risk features such as PSA >20 or cT3)
- Scheduled for radical prostatectomy
- ECOG performance status 0-1 or Karnofsky score 60 70%
- Adequate bone marrow, liver, and kidney function as defined by blood counts and liver enzyme limits
- Willingness to provide informed consent and comply with study procedures
- Willingness to use barrier contraception from first dose until prostatectomy
You will not qualify if you...
- Known lymph node involvement on CT (N1 by PSMA allowed with up to 3 lymph nodes 3 cm) or distant metastases by CT and bone scan
- Other prostate cancer types such as ductal, sarcomatous, lymphoma, small cell, or neuroendocrine tumors
- Prior radiation, hormonal, biologic, chemotherapy, immunotherapy, vaccine therapy, or experimental agents for prostate cancer
- Concurrent use of hormonal therapy or 5-reductase inhibitors
- Current or recent systemic corticosteroid use within 4 weeks
- History or presence of autoimmune disease requiring systemic immunosuppression
- History of other cancers within the last 3 years except non-melanoma skin or superficial bladder cancer
- Uncontrolled active infections, cardiovascular, pulmonary, blood, or psychiatric conditions
- Known HIV or hepatitis B/C infection without documented cure at least 6 months prior
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Northewestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21205
Actively Recruiting
3
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Not Yet Recruiting
4
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
5
XCancer - Omaha, LLC
Omaha, Nebraska, United States, 68130
Not Yet Recruiting
Research Team
C
Carolyn Chapman GU oncology
CONTACT
C
Carolyn Chapman, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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