Combo Chemotherapy for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Emmanuel Antonarakis, MD
Principal Investigator
Masonic Cancer Center, University of Minnesota
Are You a Good Fit for This Trial?
Men over 18 with advanced prostate cancer that has spread, and who have started hormone therapy within the last 3 months. They must be in good physical condition (able to perform daily activities without assistance), have not had chemotherapy or certain other treatments for prostate cancer, and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy Treatment
Participants receive a combination of ADT, carboplatin, and cabazitaxel for 6 cycles
Abiraterone Treatment
Participants start abiraterone with ADT after completing chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abiraterone
- Cabazitaxel
- Carboplatin
- Prednisone
Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Masonic Cancer Center, University of Minnesota
Lead Sponsor