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Completed

NCT Number: NCT01599793

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

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)

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Key information

Conditions

Bone Metastases Castrate-Resistant Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Recurrent Prostate Cancer Stage IV Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago

Chicago, Illinois, 60637-1470, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cabozantinib

Drug

Given PO

Other names: XL184

laboratory biomarker analysis

Other

Correlative studies

Magnetic Resonance Imaging

Procedure

Undergo MRI

Other names: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Primary outcomes

  1. Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline

    Time frame: baseline, 2 weeks

    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 outcomes

  1. 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

    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.

  2. Changes in Bone Scan Response

    Time frame: baseline, 2 weeks

    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.

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

    Time frame: baseline, 12 weeks, and 24 weeks

    The protocol proposed to collect RECIST tumor measurements at weeks 0, 12, and 24.

    However, the data were not collected

  4. Change of PSA Between 12 Weeks and Baseline

    Time frame: baseline, 12 weeks

    PSA at weeks 0, 12, and 24 were collected. Change between baseline and 12 weeks are reported

  5. Correlation of Percent Change in the Functional MRI Metrics With CTC

    Time frame: baseline, 12 weeks, and 24 weeks

    The protocol proposed to collect CTC measurements at weeks 0, 12, and 24. However, the data were not collected

  6. Change in Pain Scale Between 12 Weeks and Baseline

    Time frame: baseline,12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Endeavor Health

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2017
Study completion
2018
First posted
May 16, 2012
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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