Actively Recruiting
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy
Led by M.D. Anderson Cancer Center · Updated on 2026-05-05
42
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effects of a drug called REGN5678 in men with high-risk, localized prostate cancer. This trial aims to study how well patients tolerate REGN5678 and to assess the drug's impact on cancer pathology and immune responses within the prostate tumor and blood. The study also explores imaging biomarkers through specific PET/CT scans to better understand the drug's activity. Participants will receive REGN5678 through an intravenous infusion, with the first dose lasting about 2 hours under hospital observation to monitor for side effects. Subsequent doses may be given over 30 to 90 minutes depending on individual tolerance. Dosing occurs weekly for six weeks before participants undergo radical prostatectomy surgery. During the study, participants will have regular monitoring including blood tests and scans to evaluate safety and treatment effects. Researchers will track adverse events for about one year following treatment. The main outcome measured is the incidence of side effects graded by standard criteria. Additional assessments include pathological response after surgery and immune system changes. Participants must follow study visits and procedures throughout the trial period.
CONDITIONS
Brief Title
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men 18 years of age or older
- Histologically confirmed prostate cancer with Gleason score 8 or greater in at least 3 biopsy samples and at least 8 mm of disease on one core
- Prostate biopsy within 3 months prior to screening reviewed at MD Anderson Cancer Center
- Eastern Cooperative Oncology Group performance status of 0 or 1
- No signs of cancer spread based on bone scan and CT or MRI imaging within 60 days before enrollment
- Localized or locally advanced prostate cancer suitable for surgical removal plus pelvic lymph node dissection
- No prior prostate cancer treatments including surgery (except TURP), radiation, hormonal therapy, or chemotherapy
- Hemoglobin 11 g/dL or higher
- Absolute neutrophil count of at least 1.5 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Serum creatinine 1.5 times the upper normal limit or less, or estimated kidney function above 50 mL/min/1.73 m^2
- Total bilirubin 1.5 times the upper normal limit or less (patients with Gilbert's syndrome allowed if levels are stable)
- Liver enzymes (AST, ALT, ALP) 2.5 times the upper normal limit or less
- Consent to participate in MD Anderson laboratory protocol PA13-0291
- Willing and able to attend clinic visits and follow study procedures
- Signed informed consent
- Use of contraception with condoms during and for 3 months after study drug treatment if sexually active with women of childbearing potential
- No sperm donation during and for 3 months after study drug treatment
You will not qualify if you...
- Prior hormone therapy for prostate cancer (except 5-alpha reductase inhibitors)
- Currently enrolled in another interventional clinical trial
- Use of systemic corticosteroids over 10 mg prednisone or equivalent within 14 days before treatment
- History or suspected autoimmune disease (except certain controlled conditions like vitiligo or thyroid disorders)
- Active infections needing systemic therapy, including uncontrolled HIV or hepatitis
- Significant heart conditions within 6 months such as recent heart attack, unstable angina, serious arrhythmias, blood clots, heart failure, or pericarditis
- Major implants or devices like prosthetic heart valves or recent artificial joints
- Other cancers within 2 years except certain treated skin or bladder cancers
- Major surgery within 14 days before first study drug dose
- Neurological diseases like encephalitis, meningitis, uncontrolled seizures, or severe dementia
- Lung diseases including interstitial lung disease or pneumonitis within past 5 years
- Receipt of live vaccines within 4 weeks prior to study start
- Prior stem cell or organ transplants
- Any medical, psychological, or social condition that may interfere with study participation according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive REGN5678 by intravenous infusion weekly for 6 weeks, with the first dose given over about 2 hours and subsequent doses over 30 to 90 minutes depending on tolerance. Participants are admitted to the hospital during treatment for monitoring of side effects.
Weekly visits for 6 weeks, including hospital admission for monitoring
Duration - 1 day
After completing treatment, participants undergo radical prostatectomy with pelvic lymph node dissection to surgically remove the prostate cancer.
1 visit (in-person)
Duration - Up to 1 year
Participants are followed for safety and tolerability monitoring, including assessment of adverse events for up to 1 year after treatment completion.
Visits as scheduled for safety monitoring
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sumit Subudhi, MD, PHD
S
Sumit Sumit, MD, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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