Condition: Castration-resistant Prostate Cancer · Sponsor: Edwin Posadas, MD
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.
This description comes directly from the study's public registry record.
Clinical Trial Recruitment Navigator · 3104232133 · cancer.trial.info@cshs.org
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| City of Hope | Duarte, California, United States | Recruiting |
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Recruiting |
| Huntsman Cancer Institute and Hospital | Salt Lake City, Utah, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05534646