A Phase II Study of MRI Based Functional Imaging for the Evaluation of Bone Metastasis in Men With Castrate Resistant Prostate Cancer Receiving XL184
I. To determine effect of XL184 on the functional MRI metrics Ktrans and apparent diffusion
coefficient (ADC) within castrate resistant prostate cancer bone metastases.
I. To quantify progression free survival in men with castrate resistant prostate cancer
(CRPC) treated with XL184 according to Prostate Cancer Working Group criteria.
II. To correlate and changes in MRI based functional metrics with bone scan, prostate
specific antigen (PSA), Response Evaluation Criteria in Solid Tumors (RECIST) response
criteria, circulating tumor cells (CTC) number and with changes in pain.
III. To explore c-MET, phospho-c-MET staining on circulating tumor cells as a predictive
biomarker for response and duration of response to XL-184.
Patients receive cabozantinib orally (PO) once daily (QD). Treatment continues in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Vascular permeability as captured by the Ktrans parameter
Tested by performing a paired t-test. A 95% confidence interval for the magnitude of the mean change will be generated.
At 2 weeks
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Chicago||Chicago, Illinois 60637|