A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and the Microenvironment in Men With Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer
I. To assess the impact of cabozantinib on markers of bone turnover and microenvironment in
men with non-metastatic castration-resistant prostate cancer and to compare the findings in
men with metastatic castration-resistant prostate cancer.
I. To describe the associated changes in dynamic histomorphometry at baseline and after 6
weeks of cabozantinib therapy in men with non-metastatic castration-resistant prostate
II. To characterize, describe, and compare the effects of cabozantinib in men with
non-metastatic and metastatic bone disease with respect to the following measurements at
baseline and on therapy: markers of bone metabolism in blood including bone specific
alkaline phosphatase, alkaline phosphatase, lactate dehydrogenase (LDH); changes in markers
of apoptosis, proliferation, and angiogenesis in biopsy specimens from both bone and soft
tissue during therapy with cabozantinib.
I. Radiographic disease responses and toxicities will be monitored for all patients.
Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in urinary N-telopeptide (uNTX)
Will be analyzed after log-transformation.
Baseline and 6 weeks
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Seattle Cancer Care Alliance/University of Washington||Seattle, Washington 98109|