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

Primary Purpose

Bone Metastases, Castrate-resistant Prostate Cancer, Recurrent Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cabozantinib
laboratory biomarker analysis
magnetic resonance imaging
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Metastases focused on measuring castrate resistant prostate cancer, CRPC, cabozantinib, XL184

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (enzyme inhibitor therapy)

Arm Description

Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline
Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion. To determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported.

Secondary Outcome Measures

Association of Progression Free Survival (PFS) With Ktrans and ADC
Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. The approximate survival after standard therapies in this setting is bleak and in the order of months. Too few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses. Therefore, we calculated the median PFS time and its 95% confidence interval.
Changes in Bone Scan Response
Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome.
Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements
The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24. However, the data were not collected
Change of PSA Between 12 Weeks and Baseline
PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported
Correlation of Percent Change in the Functional MRI Metrics With CTC
The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected
Change in Pain Scale Between 12 Weeks and Baseline
Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported . In the pain score ranged from 0 to 10. 10 denotes most pain.

Full Information

First Posted
May 14, 2012
Last Updated
March 25, 2020
Sponsor
University of Chicago
Collaborators
NorthShore University HealthSystem
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1. Study Identification

Unique Protocol Identification Number
NCT01599793
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases, Castrate-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
Keywords
castrate resistant prostate cancer, CRPC, cabozantinib, XL184

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (enzyme inhibitor therapy)
Arm Type
Experimental
Arm Description
Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
cabozantinib
Other Intervention Name(s)
XL184
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo MRI
Primary Outcome Measure Information:
Title
Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline
Description
Ktrans is a measurement calculating the volume transfer constant of the contrast reagent and essentially is a measurement of vascular perfusion. To determine the effect of XL184 on the functional MRI metrics Ktrans, Ktrans parameters were measured at baseline, two week time-point, 12 weeks, and 24 weeks for disease monitoring. Change between baseline and 2 weeks reported.
Time Frame
baseline, 2 weeks
Secondary Outcome Measure Information:
Title
Association of Progression Free Survival (PFS) With Ktrans and ADC
Description
Time to progression or progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. The approximate survival after standard therapies in this setting is bleak and in the order of months. Too few events for a meaningful statistical analysis; no significant results were obtained in Cox regression analyses. Therefore, we calculated the median PFS time and its 95% confidence interval.
Time Frame
From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year
Title
Changes in Bone Scan Response
Description
Bone Scan Response at weeks 2, 12, and 24 were collected. Change between baseline and 2 weeks are reported Bone Scan Response were measured as increase, decrease, or stable of bone lesions and scored as 1, -1, or 0, respectively, where higher values represent a worse outcome.
Time Frame
baseline, 2 weeks
Title
Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements
Description
The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24. However, the data were not collected
Time Frame
baseline, 12 weeks, and 24 weeks
Title
Change of PSA Between 12 Weeks and Baseline
Description
PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported
Time Frame
baseline, 12 weeks
Title
Correlation of Percent Change in the Functional MRI Metrics With CTC
Description
The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected
Time Frame
baseline, 12 weeks, and 24 weeks
Title
Change in Pain Scale Between 12 Weeks and Baseline
Description
Pain scores are measured at baseline and weeks 12, and 24. Change between baseline and 12 weeks are reported . In the pain score ranged from 0 to 10. 10 denotes most pain.
Time Frame
baseline,12 weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell Szmulewitz
Organizational Affiliation
University of Chicago Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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