An Observational Study of XL-184 Cabozantinib and Androgen Ablation in Patients With Androgen-Dependent Metastatic Prostate Cancer
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take 1 capsule of
cabozantinib by mouth 1 time every day while you are on study. You should not eat or drink
anything other than water for 2 hours before and 1 hour after taking the study drug. You
should take the capsule with at least 1 cup (8 ounces) of water. You will also be given
separate directions about how to take the study drug.
You will also receive hormone therapy. The hormone drug you receive will be standard of
care hormone therapy. The study doctor will decide what hormone therapy you will receive and
will explain when and how you should take the hormone therapy, as well as its risks.
You will be given a drug diary where you will record when you take cabozantinib. You should
return this diary to the study staff when you come into the clinic.
At every visit, you will be asked about any side effects you may have had and any other
drugs you may be taking.
Every 3 weeks for the first 12 weeks of the study, and then every 6 weeks after that:
- You will have a physical exam.
- Blood (about 3-4 teaspoons) will be drawn for routine tests. Every 6 weeks, this blood
will also be used to measure your PSA.
- Urine will be collected for routine tests (every 6 weeks).
Every 12 weeks, you will have a bone scan and CT scans of the chest, abdomen, and pelvis to
check the status of the disease.
Length of Study:
You may continue receiving the study drug for as long as the study doctor thinks it is in
your best interest. You will be taken off study early if the disease gets worse, if you
have intolerable side effects, or if your study doctor thinks it is in your best interest to
You will be contacted every 6 months after you stop taking the study drug to check on how
you are feeling and the status of the disease. This will consist of a phone call, e-mail,
or medical record review. If you are called, each call should last about 5 minutes.
This is an investigational study. Cabozantinib is FDA approved to treat patients with
certain types of thyroid cancer. Its use in this study is investigational.
Up to 60 participants will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival
Castrate-resistant progression defined by any of the following: (a) radiographic progression (using RECIST 1.1 for visceral disease and PCWG2 for Bone Scans), (b) receipt of additional anti-cancer therapy, or (c) clinical progression warranting discontinuation from the study as judged by the treating physician.
Paul Corn, MD, PHD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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