This trial is examining the safety and effectiveness of cabazitaxel (Jevtana) with abiraterone acetate (Zytiga) compared to abiraterone acetate alone for metastatic (cancer that has spread) castration-resistant prostate cancer (cancer that is no longer responding to hormone therapy). The main outcome measured will be the progression-free survival (the time that the disease does not get worse).
In prostate cancer, the androgen hormones (such as testosterone) have been shown to increase the growth of cancers. Therapy that uses anti-androgen (like abiraterone) may fight prostate cancer by blocking tumor cells from getting hormones. Chemotherapy drugs (like cabazitaxel) may be more effective in fighting tumor cells with anti-androgen drugs.
The purpose of this study is to see if prostate cancer can be better treated with a combination of abiraterone and cabazitaxel. The main outcome to be measured in this study is how do cabazitaxel and abiraterone prevent the growth of metastatic prostate cancer that has been resistant to hormone therapy. Other outcomes measured will be changes in the PSA (a protein elevated in prostate cancer) levels and overall survival, as well as side effects.
Who are they looking for?
This study is looking to recruit 210 patients with metastatic prostate cancer. Patients must have progressive disease despite having used castration (lowering hormone) therapy, and have a very low level of testosterone (below 50ng/dl or 1.73nmol/l). Patients must have been on the drug docetaxel for at least 3 cycles. Sexually active men must agree to use contraception or abstain from sexual intercourse for the duration of the study and another 26 weeks after the last dose of treatment.
Patients should not have any other active cancers, signs of liver disease, or active infections. Patients also should have any other conditions where a steroid drug could not be used. Patients with severe heart conditions such as a recent heart attack, heart failure or uncontrolled chest pain are not eligible. Patients must not have had radiation therapy from outside the body 4 weeks before the study.
How will it work
In this study, there will be two groups. One group will receive abiraterone with prednisone (a steroid hormone) tablets and cabazitaxel intravenously (injected in the vein)and one will receive only abiraterone with prednisone. Both groups will receive standard anti-androgen therapies. Abiraterone and prednisone will be given on days 1-21 for six cycles. Cabazitaxel will be given over an hour on day one of each cycle. Patients will be followed up with every 3-6 months and then yearly for up to five years.