Spots Global Cancer Trial Database for Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Official Title: Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
Study ID: NCT05534646
Conditions
Study Description
Brief Summary: This is an open-label, multi-site study of apalutamide with carotuximab in patients who have progressed on androgen receptor signaling inhibitor (ARSI) therapy. This study will begin with a safety assessment in the first 10 subjects (part 1: Safety Lead-in). If the combination is deemed safe, the trial will proceed to the Phase II stage. The purpose of this study is to compare progression free survival (PFS) between patients receiving apalutamide and apalutamide + carotuximab using Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3. The secondary objectives are to describe adverse events related to the intervention, overall response rate (ORR), proportion of patients resistant to apalutamide that benefit from the addition of carotuximab, and to determine the ORR, radiographic PFS, and biochemical PFS in the overall population.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Cedars-Sinai Medical Center, Los Angeles, California, United States
Contact Details
Name: Edwin Posadas, MD FACP
Affiliation: Cedars-Sinai Medical Center
Role: PRINCIPAL_INVESTIGATOR
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