Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer
Condition: Bone Metastases; Castrate-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms; Neoplasm Metastasis
Intervention: cabozantinib; laboratory biomarker analysis; magnetic resonance imaging
Intervention description: Given PO; Correlative studies; Undergo MRI
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Male
Healthy volunteers: No
Keywords: castrate resistant prostate cancer; CRPC; cabozantinib; XL184

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)
    

Eligibility criteria:

        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 requires concomitant treatment, in therapeutic doses, with anticoagulants