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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01599793
Recruitment Status : Active, not recruiting
First Posted : May 16, 2012
Last Update Posted : February 2, 2018
NorthShore University HealthSystem
Information provided by (Responsible Party):
University of Chicago

Brief 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)

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

Detailed Description:


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)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment (enzyme inhibitor therapy)
Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: cabozantinib
Given PO
Other Name: XL184

Other: laboratory biomarker analysis
Correlative studies

Procedure: magnetic resonance imaging
Undergo MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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 ]
  2. Correlation of percent change in the functional MRI metrics to changes in bone scan [ Time Frame: Assessed up to 1 year ]
  3. Correlation of percent change in the functional MRI metrics to RECIST tumor measurements [ Time Frame: Assessed up to 1 year ]
  4. Correlation of percent change in the functional MRI metrics with PSA [ Time Frame: Assessed up to 1 year ]
  5. Correlation of percent change in the functional MRI metrics with CTC [ Time Frame: Assessed up to 1 year ]
  6. Correlation of percent change in the functional MRI metrics with pain scale changes [ Time Frame: Assessed up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed prostate cancer with progressive disease
  • Evidence of castration resistance defined as disease progression despite a testosterone level < 50ng/dL (or surgical castration)
  • Evidence of metastatic disease to the bones within the lumbar spine, sacrum, or pelvic bones that is identifiable on screening pelvic MRI
  • If patient has had prior pelvis radiation therapy (RT), then bone metastases must be out of radiated port (e.g. lumbar or sacral spine)
  • Any prior therapy for castrate disease acceptable other than prior XL184 with a minimum washout of 28 days for any other anticancer therapy
  • Patients with castrate resistant disease post antiandrogen therapy/withdrawal must meet at least one of the following criteria:

    • Have not received docetaxel chemotherapy
    • Have received docetaxel chemotherapy but received less then 225mg/m2 cumulative dose
    • Have documented liver metastases
    • Have no pain or pain that does not require a long acting (SR) narcotic
    • Have received mitoxantrone chemotherapy in the past for CRPC

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study
  • Patients who are receiving any other investigational agents
  • Prior treatment with other vascular endothelial growth factor (VEGF) or c-MET targeted therapies
  • History of hematemesis or hemoptysis
  • The subject has uncontrolled or significant intercurrent illness
  • The patient requires concomitant treatment, in therapeutic doses, with anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01599793

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
University of Chicago
NorthShore University HealthSystem
Principal Investigator: Russell Szmulewitz University of Chicago Comprehensive Cancer Center
  Study Documents (Full-Text)

Documents provided by University of Chicago:

Responsible Party: University of Chicago Identifier: NCT01599793     History of Changes
Other Study ID Numbers: 12-1031
NCI-2012-00677 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Keywords provided by University of Chicago:
castrate resistant prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases