Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resi… (NCT01599793) | Clinical Trial Compass
CompletedPhase 2
Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer
United States19 participantsStarted 2012-05
Plain-language summary
This study is being done to help researchers understand more about prostate cancer that has spread to the bones by using the newest magnetic resonance imaging (MRI) techniques and to better understand the effect of an experimental drug called XL184 (or cabozantinib) on bone disease. The other purposes of the study are to better understand the effect of XL184 on prostate cancer progression, bone pain, and on any cancer cells that patients may have circulating within the blood (called circulating tumor cells)
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically or cytologically confirmed prostate cancer with progressive disease
* Evidence of castration resistance defined as disease progression despite a testosterone level \< 50ng/dL (or surgical castration)
* Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI
* If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)
* Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy
* Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria:
* Have not received docetaxel chemotherapy
* Have received docetaxel chemotherapy but received less then 225mg/m2 cumulative dose
* Have documented liver metastases
* Have no pain or pain that does not require a long acting (SR) narcotic
* Have received mitoxantrone chemotherapy in the past for CRPC
Exclusion Criteria:
* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
* Patients who are receiving any other investigational agents
* Prior treatment with other vascular endothelial growth factor (VEGF) or c-MET targeted therapies
* History of hematemesis or hemoptysis
* The subject has uncontrolled or significant intercurrent illness
* The patient r…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline