Clinical trial NCT01599793: Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Metastases
Castrate-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Keywords: castrate resistant prostate cancer
CRPC
cabozantinib
XL184
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Endeavor Health
First posted: 2012-05-16
Enrollment: 19
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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)

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 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

Primary outcomes:
measure: Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline
timeFrame: baseline, 2 weeks
Secondary outcomes:
measure: Association of Progression Free Survival (PFS) With Ktrans and ADC
timeFrame: From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year
measure: Changes in Bone Scan Response
timeFrame: baseline, 2 weeks
measure: Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements
timeFrame: baseline, 12 weeks, and 24 weeks
measure: Change of PSA Between 12 Weeks and Baseline
timeFrame: baseline, 12 weeks
measure: Correlation of Percent Change in the Functional MRI Metrics With CTC
timeFrame: baseline, 12 weeks, and 24 weeks
measure: Change in Pain Scale Between 12 Weeks and Baseline
timeFrame: baseline,12 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago Comprehensive Cancer Center
name: Russell Szmulewitz
role: PRINCIPAL_INVESTIGATOR
References: