Cabozantinib in Treating Men With Castration-Resistant Prostate Cancer
Adenocarcinoma of the Prostate
Castration-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Change in urinary N-telopeptide (uNTX) [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Will be analyzed after log-transformation.
- Toxicity assessed using CTCAE version 4.0 [ Time Frame: Up to 4 weeks post-treatment ] [ Designated as safety issue: Yes ]Toxicity will be described by grade and frequency.
- Progression-free survival [ Time Frame: Up to 4 weeks post-treatment ] [ Designated as safety issue: No ]Kaplan-Meier methods will be used to report progression-free survival.
- Time to progression [ Time Frame: From date of registration to date of progressive disease, assessed up to 4 weeks post-treatment ] [ Designated as safety issue: No ]Kaplan-Meier methods will be used to report time to progression.
- Objective response [ Time Frame: Up to 4 weeks post-treatment ] [ Designated as safety issue: No ]Proportions and 95% binomial confidence intervals will be reported for objective response.
- PSA response [ Time Frame: Up to 4 weeks post-treatment ] [ Designated as safety issue: No ]Proportions and 95% binomial confidence intervals will be reported for PSA response.
- Duration of response [ Time Frame: Up to 4 weeks post-treatment ] [ Designated as safety issue: No ]Mean and the corresponding standard deviation will be used to describe the duration of response among responders.
- Changes in dynamic histomorphometry of involved and uninvolved bone [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]Logistic models will be used.
- Changes in bone and serum markers of bone metabolism [ Time Frame: Baseline, 6 weeks and 12 weeks ] [ Designated as safety issue: No ]Will be explored using a linear mixed model to determine if there is a difference in these markers over time between patients with progressive disease and those without.
|Study Start Date:||September 2013|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (cabozantinib)
Patients receive cabozantinib PO QD in the absence of disease progression or unacceptable toxicity.
Other Names:Other: laboratory biomarker analysis
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 cancer.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01703065
|United States, Washington|
|Seattle Cancer Care Alliance/University of Washington||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Celestia S. Higano 206-288-6389 email@example.com|
|Principal Investigator: Celestia S. Higano|
|Principal Investigator:||Celestia Higano||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|