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EA8153 Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
Protocol Number:
Phase II
Channing Paller
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The purpose of this research study is to compare any good or bad effects of using the chemotherapy drug cabazitaxel (also known as Jevtana®) with the usual approach of the hormone based therapy abiraterone acetate (also known as Zytiga®) in combination with prednisone on patients with advanced prostate cancer that have already undergone treatment with hormone therapy and the chemotherapy drug docetaxel.
Patients with prostate cancer that has spread, and is able to grow even though drugs or other treatments to lower the amount of male sex hormones are being used to manage the cancer may be eligible.
This research study has two study groups. Group A will receive the study drug cabazitaxel in addition to the standard of care combination of abiraterone acetate and prednisone, and Group B will receive the standard of care combination of abiraterone acetate and prednisone. All patients will continue androgen deprivation, which is the standard of care.A computer will assign you by chance to a treatment group in the research study. This is called randomization. This is done by chance because no one knows if one study group is better or worse than the other.If you are in Group A you will receive treatment with abiraterone acetate once daily, prednisone twice daily, and cabazitaxel once every 21 days for up to 6 times on this study. The 21-day period from one treatment with cabazitaxel to the next is called a cycle. As such you will receive up to 6 cycles of treatment with cabazitaxel for a total of 126 days. After you finish treatment with cabazitaxel, you will continue treatment with abiraterone acetate and prednisone. If you are in Group B you will receive treatment with abiraterone acetate once daily, and prednisone twice daily. In either group, you will be asked to take abiraterone acetate and prednisone until your cancer gets worse or until you or your doctor decides that it is in your best interest to stop the study. After you are finished taking the study drugs, your doctor will ask you to visit the office for at least one follow-up exam. If you are no longer seeing your study doctor, a staff member will call you on the telephone. The doctor would like to see how you are doing every 3 months if you are less than 2 years from study entry, every 6 months if you are 2-3 years from study entry and then annually for up to year 5. Keeping in touch with you and checking on your condition helps the study staff look at the long-term effects of the study.
Last Update
08/08/2020 05:02 AM