Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01599793

Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer

Bone Metastases Clinical Trial

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

Clinical Trial 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)

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine effect of XL184 on the functional MRI metrics Ktrans and apparent diffusion coefficient (ADC) within castrate resistant prostate cancer bone metastases.

SECONDARY OBJECTIVES:

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.

OUTLINE:

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01599793
Study type Interventional
Source University of Chicago
Contact
Status Completed
Phase Phase 2
Start date May 2012
Completion date December 2018
View Details
See also
  Status Clinical Trial Phase
Terminated NCT03986593 - Cryoablation of Bone Metastases From Endocrine Tumors N/A
Active, not recruiting NCT01996046 - FDG PET/CT in Breast Cancer Bone Mets
Completed NCT01358539 - Palliation: the Effect of Education on Pain Phase 3
Terminated NCT00981578 - ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain N/A
Terminated NCT00757757 - A Phase I/II Open-label Study of MCS110 in Patients With Prostate Cancer and Bone Metastases Phase 1/Phase 2
Completed NCT00762346 - Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis Phase 4
Completed NCT00420433 - Bone Response in Metastatic Breast Cancer Involving Bones N/A
Completed NCT02826382 - Preliminary Evaluation of Uptake in Bone Metastases and Biodistribution of [68Ga]P15-041 Early Phase 1
Terminated NCT05301062 - A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
Recruiting NCT06367491 - National Database of Bone Metastases
Completed NCT03223727 - Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
Completed NCT00830180 - Open Label Extension In Cancer Patients Phase 2
Active, not recruiting NCT03305224 - The Combination Therapy With Ra-223 and Enzalutamide Phase 2
Withdrawn NCT04109937 - External Beam Radiation Therapy Post Surgery in Patients With Lower Extremity Bone Metastases Randomized Efficacy Trial N/A
Active, not recruiting NCT02880943 - Dose-finding, Safety and Efficacy Study of Radium-223 Dichloride (XOFIGO) in RCC Patients With Bone Metastases. (EIFFEL) Phase 1/Phase 2
Completed NCT01696760 - Aspirin and Compression Devices for VTE Prophylaxis in Orthopaedic Oncology N/A
Completed NCT00958477 - A Study to Determine the Safety, Tolerability, Pharmacokinetics and Dynamic Effects of Different Doses of the Study Drug EMD 525797 in Prostate Cancer Phase 1
Completed NCT03979118 - Exercise Prescription in Patients With Bone Metastases
Completed NCT03353090 - Double-bed SPECT/CT for Bone Scintigraphy in Initial Staging of Cancer Patients N/A
Recruiting NCT05167669 - Pain Relief in Symptomatic Bone Metastases With Adjuvant Hyperthermia MR Guided HIFU Early Phase 1