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

NCT01599793 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 12-1031NCI-2012-00677
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Keywords

castrate resistant prostate cancer; CRPC; cabozantinib; XL184

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 2 weeks

Secondary Outcomes (6)

• Association of Progression Free Survival (PFS) With Ktrans and ADC

  From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year

• Changes in Bone Scan Response

  baseline, 2 weeks

• Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements

  baseline, 12 weeks, and 24 weeks

• Change of PSA Between 12 Weeks and Baseline

  baseline, 12 weeks

• Correlation of Percent Change in the Functional MRI Metrics With CTC

  baseline, 12 weeks, and 24 weeks

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

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

Drug: cabozantinib; Other: laboratory biomarker analysis; Procedure: magnetic resonance imaging

Interventions

cabozantinib DRUG

Given PO

Also known as: XL184

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

magnetic resonance imaging PROCEDURE

Undergo MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Endeavor Health: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabozantinib; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Russell Szmulewitz, MD
• Organization: University of Chicago

rszmulew@medicine.bsd.uchicago.edu

773-702-7609

Study Officials

• Russell Szmulewitz

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2012
• First Posted: May 16, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 26, 2020
• Results First Posted: March 26, 2020

Record last verified: 2020-03

Locations

US (1)