Protocol
12-274
Full Title
A Phase 3, Randomized, Double-blind, Controlled Study of Cabozantinib (XL184) vs. Prednisone in Metastatic Castration-resistant Prostate Cancer Patients who have Received Prior Docetaxel and Prior Abiraterone or MDV3100
Purpose
Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies (and are called “castration-resistant” prostate cancer).
In this study, researchers want to compare the effectiveness of the investigational drug cabozantinib (XL184) with standard therapy (prednisone) in men with metastatic castration-resistant prostate cancer that continued to spread despite prior treatment with docetaxel and either abiraterone or MDV3100 (enzalutamide). Cabozantinib blocks several proteins (called MET, RET, and vascular endothelial growth factor receptor 2) that help keep cancer cells alive. It is a capsule that is taken orally (by mouth).
Patients will be randomly assigned to receive cabozantinib (2/3 of the patients) or prednisone (1/3 of the patients), but not both. Patients in each group will also receive a placebo pill that is similar to the drug that the other group is taking. Researchers will evaluate the effects of these treatments on bone metastases and survival.
Investigator
Co-Investigators
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have metastatic castration-resistant prostate cancer that continued to spread despite prior treatment with docetaxel and either abiraterone or MDV3100 (enzalutamide).
- Patients must have evidence of bone metastases and a serum testosterone level below 50 ng/dL.
- At least 2 weeks must have passed since completion of prior therapy (4 weeks since radiation therapy and 6 weeks since radionuclide treatment) and entry into the study.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- This study is open to patients age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Dana Rathkopf at 646-422-4379.
Disease(s)
Prostate Cancer
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
Related Diseases
