Bone MetastasesPhase 2NCT01599793
Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer
A Phase 2 study testing cabozantinib, laboratory biomarker analysis and magnetic resonance imaging in people with Bone Metastases and Castrate-resistant Prostate Cancer, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Bone Metastases, Castrate-resistant Prostate Cancer, Recurrent Prostate Cancer
- What is being tested?
- cabozantinib, laboratory biomarker analysis and magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- cabozantinib, laboratory biomarker analysis, magnetic resonance imaging
- Keywords
- castrate resistant prostate cancer, CRPC, cabozantinib, XL184
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cabozantinibDrug
Also called XL184
Given PO
laboratory biomarker analysisOther
Correlative studies
magnetic resonance imagingProcedure or surgery
Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: cabozantinib; Other: laboratory biomarker analysis; Procedure: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 2 weeks
Secondary outcomes (6)
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.
Measured: From start of treatment to time of progression or death, whichever occurs first, assessed up to 1 year
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.
Measured: baseline, 2 weeks
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
Measured: baseline, 12 weeks, and 24 weeks
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
Measured: baseline, 12 weeks
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
Measured: baseline, 12 weeks, and 24 weeks
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.
Measured: baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Endeavor Health
- Responsible party
- Sponsor
- Investigators
- Russell Szmulewitz, Principal investigator, University of Chicago Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599793
- Sponsor's protocol ID
- 12-1031
- Other IDs
- NCI-2012-00677
- Status last verified
- Mar 2020
- First submitted
- 14 May 2012
- Last updated
- 26 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01599793
- Acronym / sponsor ID
- 12-1031
- Conditions
- Bone Metastases, Castrate-resistant Prostate Cancer, Recurrent Prostate Cancer, Stage IV Prostate Cancer
- Keywords
- castrate resistant prostate cancer, CRPC, cabozantinib, XL184
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Endeavor Health
- Study start
- May 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 26 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Drug: cabozantinib, Other: laboratory biomarker analysis, Procedure: magnetic resonance imagingPatients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cabozantinibAlso: XL184Given PO | Drug | Treatment (enzyme inhibitor therapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (enzyme inhibitor therapy) |
| magnetic resonance imagingAlso: MRI, NMR imaging, NMRI, nuclear magnetic resonance imagingUndergo MRI | Procedure or surgery | Treatment (enzyme inhibitor therapy) |
Primary outcome
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.
6 secondary outcomes
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
Changes in Bone Scan Response
Time frame: baseline, 2 weeks
Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements
Time frame: baseline, 12 weeks, and 24 weeks
Change of PSA Between 12 Weeks and Baseline
Time frame: baseline, 12 weeks
Correlation of Percent Change in the Functional MRI Metrics With CTC
Time frame: baseline, 12 weeks, and 24 weeks
Change in Pain Scale Between 12 Weeks and Baseline
Time frame: baseline,12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Szmulewitz principal investigator
University of Chicago Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cabozantinib, laboratory biomarker analysis and magnetic resonance imaging in people with Bone Metastases and Castrate-resistant Prostate Cancer, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline (time frame: baseline, 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.