Spots Global Cancer Trial Database for A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
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Trial Identification
Brief Title: A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
Official Title: A Pilot Presurgical Trial of REGN5678 (Anti-PSMA X CD28) in Patients With High-Risk, Localized Prostate Cancer Followed by Radical Prostatectomy
Study ID: NCT06085664
Study Description
Brief Summary: To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.
Detailed Description: 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
M D Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Sumit K Subudhi, MD, PHD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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