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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Collaborator:
NorthShore University HealthSystem
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01599793
First received: May 14, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Vascular permeability as captured by the Ktrans parameter [ Time Frame: At 2 weeks ] [ Designated as safety issue: No ]
    Tested by performing a paired t-test. A 95% confidence interval for the magnitude of the mean change will be generated.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Correlation of percent change in the functional MRI metrics to changes in bone scan [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]
  • Correlation of percent change in the functional MRI metrics to RECIST tumor measurements [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]
  • Correlation of percent change in the functional MRI metrics with PSA [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]
  • Correlation of percent change in the functional MRI metrics with CTC [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]
  • Correlation of percent change in the functional MRI metrics with pain scale changes [ Time Frame: Assessed up to 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: May 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599793

Contacts
Contact: Elia Martinez, RN 773-702-3623

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Russell Z. Szmulewitz    773-702-7609    rszmulew@medicine.bsd.uchicago.edu   
Principal Investigator: Russell Z. Szmulewitz         
Sponsors and Collaborators
University of Chicago
NorthShore University HealthSystem
Investigators
Principal Investigator: Russell Szmulewitz University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01599793     History of Changes
Other Study ID Numbers: 12-1031, NCI-2012-00677
Study First Received: May 14, 2012
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
castrate resistant prostate cancer
CRPC
cabozantinib
XL184

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

ClinicalTrials.gov processed this record on September 16, 2014