The purpose of this study is to determine what effects (good and bad) cabozantinib has in
treatment of patients with metastatic castrate resistant prostate cancer (mCRPC).
The hypothesis for this trial is that cabozantinib has anti-tumor activity in a
molecularly-selected group of patients with CRPC.
This is a single-arm, open-label Phase II multi-institutional trial in 30 patients that have
been molecularly selected based on that their tumors possess alterations in molecular targets
of cabozantinib. Patients will be treated be continuously until they develop radiographic
progression or discontinue cabozantinib for toxicity. If 6 or more out of 12 subjects with
particular mutation or gene amplification show progression prior to 6 months, accrual for the
particular genomic alteration may close. In addition, a series of correlative studies will be
performed including tissue biopsies in order to further define the mechanisms of cabozantinib
anti-tumor action in prostate cancer and identify surrogate markers of response.
This research study is being done because additional effective treatments are needed for
prostate cancer that has spread and is growing despite hormone suppression. Prior studies
indicate that Cabozantinib may be effective in a subset of these participants, but that has
not yet been determined.
About 30 subjects will take part in this study at 4 participating sites. We expect to enroll
approximately 20 participants at Weill Cornell Medicine and approximately 3-5 subjects per
participating site. All subjects participating in this study will be treated with
Cabozantinib. All subjects will continue to take LHRH analogue therapy.
Once eligible participants will be enrolled on the trial for approximately approximately 12
months. At that point, subjects will switch to long-term follow up for two years after
removal from the study or until death, whichever occurs first.
Study related procedures can be combined with routine Standard of Care (SOC) visits. These
will include obtaining medical history, vitals, routine blood collection, radiographic
imaging (CT, MRI and Bone scan), EKG and between 2 and 4 weeks after starting therapy, a
tumor biopsy is required. This will be done with a needle by local sedation by an
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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