Prostate Cancer Clinical Trial
Official title:
A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy
To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.
Primary Objectives: • To evaluate safety and tolerability of REGN5678 (antiPSMAxCD28) in patients with high-risk, localized prostate cancer. Secondary Objectives: • To assess the proportion of patients who achieve pathological response with REGN5678 in men with high-risk, localized prostate cancer. Exploratory Objectives: - To evaluate immune responses in the prostate tumor microenvironment and peripheral blood after treatment with REGN5678 as compared to pre-treatment samples and untreated control samples. - To evaluate efficacy of REGN5678 in men with high-risk, localized prostate cancer. To evaluate exploratory imaging biomarkers for REGN5678 by PSMA PET/CT and FDG PET/CT ;
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