Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib on Bone Metastases in Patients With Castrate Resistant Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01599793|
Recruitment Status : Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases Castrate-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer||Drug: cabozantinib Other: laboratory biomarker analysis Procedure: magnetic resonance imaging||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of MRI Based Functional Imaging for the Evaluation of Bone Metastasis in Men With Castrate Resistant Prostate Cancer Receiving XL184|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Other Name: XL184
Other: laboratory biomarker analysis
Procedure: magnetic resonance imaging
- Vascular permeability as captured by the Ktrans parameter [ Time Frame: At 2 weeks ]Tested by performing a paired t-test. A 95% confidence interval for the magnitude of the mean change will be generated.
- Association of progression free survival (PFS) with Ktrans and ADC [ Time Frame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year ]
- Correlation of percent change in the functional MRI metrics to changes in bone scan [ Time Frame: Assessed up to 1 year ]
- Correlation of percent change in the functional MRI metrics to RECIST tumor measurements [ Time Frame: Assessed up to 1 year ]
- Correlation of percent change in the functional MRI metrics with PSA [ Time Frame: Assessed up to 1 year ]
- Correlation of percent change in the functional MRI metrics with CTC [ Time Frame: Assessed up to 1 year ]
- Correlation of percent change in the functional MRI metrics with pain scale changes [ Time Frame: Assessed up to 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599793
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Russell Szmulewitz||University of Chicago Comprehensive Cancer Center|