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Brief Title: CASCARA: Castration Sensitive Carboplatin, Cabazitaxel and Abiraterone
Official Title: A Phase II Study of Carboplatin, Cabazitaxel and Abiraterone in High Volume Metastatic Castration Sensitive Prostate Cancer
Study ID: NCT03934840
Brief Summary: This is a phase II clinical trial in patients with metastatic castration sensitive prostate cancer. The objective of the study is to determine the efficacy and further define the safety of the treatment combination. This study will evaluate dose levels of carboplatin AUC 4 with cabazitaxel 20 mg/m2. Patients will be treated with the combination of ADT and carboplatin and cabazitaxel for 6 cycles. After 6 cycles of chemotherapy, they will start abiraterone with ADT. The primary objective is to determine the percent of subjects that have no PSA or radiographic progression at 1 year. Secondary objectives will include determining the progression-free survival, time to PSA nadir and time to PSA progression of carboplatin and cabazitaxel in combination with ADT.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Mayo Clinic Arizona, Phoenix, Arizona, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Tulane University, New Orleans, Louisiana, United States
Masonic Cancer Center at University of Minnesota, Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
Thomas Jeferson University, Philadelphia, Pennsylvania, United States
Lifespan Cancer Institute, Providence, Rhode Island, United States
Name: Emmanuel Antonarakis, MD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: PRINCIPAL_INVESTIGATOR