What is the Purpose of this Study?
This study will evaluate an experimental drug called carotuximab when taken in combination with apalutamide, in comparison to apalutamide alone, for the treatment of metastatic, castration-resistant prostate cancer. Carotuximab is a genetically engineered antibody (type of protein). Researchers aim to determine whether patients experience an increased length of time during treatment in which the cancer does not worsen. The study will also assess how well the body responds to the treatment of carotuximab when taken with apalutamide. The study will also examine immune cells and tumor biomarkers by collecting blood and tissue from participants. A biomarker is a biological molecule found in body fluids or tissues that may be a sign of a disease and can be used to predict response to a specific treatment.
Eligibility
- * History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contemporary ARSIs
- * Patient must have had 1 and can have up to 2 prior AR targeted therapy with the exception of apalutamide.
- * Patients must decline or be ineligible for taxane therapy in the opinion of the treating physician.
- * All patients must agree to use an adequate method of contraception, in the opinion of the treating investigator, while on protocol treatment and for 3 months after the last dose of protocol treatment (apalutamide and/or carotuximab)
Where can I participate?
- CS Cancer Tarzana : Maria Tarallo
- CS Cancer at Beverly Hills : Maria Tarallo
- CS Cancer at Cedars-Sinai Medical Center : Maria Tarallo
- CS Cancer at The Angeles Clinic and Research Institute : Maria Tarallo
More about this Clinical Trial
What is the full name of this clinical trial?
IIT2021-06-POSADAS-APA105: Phase II study of apalutamide with carotuximab in metastatic, castration-resistant prostate cancer