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Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Castration-resistant Prostate Cancer Clinical Trial

Official title:
Phase II Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05534646
Study type Interventional
Source Cedars-Sinai Medical Center
Contact Clinical Trial Recruitment Navigator
Phone 3104232133
Email cancer.trial.info@cshs.org
Status Recruiting
Phase Phase 2
Start date December 27, 2023
Completion date January 2027
View Details
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