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

NCT ID: NCT01599793

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2018-12-31

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.

Conditions

Bone Metastases; Castrate-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Treatment (enzyme inhibitor therapy)

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

Group Type: EXPERIMENTAL

cabozantinib

Intervention Type: DRUG

Given PO

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

magnetic resonance imaging

Intervention Type: PROCEDURE

Undergo MRI

Interventions

cabozantinib

Given PO

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

magnetic resonance imaging

Undergo MRI

Intervention Type: PROCEDURE

Other Intervention Names

XL184; MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Szmulewitz

Role: PRINCIPAL_INVESTIGATOR

University of Chicago Comprehensive Cancer Center

Locations

University of Chicago

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2012-00677

Identifier Type: REGISTRY

Identifier Source: secondary_id

12-1031

Identifier Type: -

Identifier Source: org_study_id