Clinical trial · Interventional
Magnetic Resonance Imaging in Measuring the Effect of Cabozantinib in Patients With Castrate Resistant Prostate Cancer
A Phase II Study of MRI Based Functional Imaging for the Evaluation of Bone Metastasis in Men With Castrate Resistant Prostate Cancer Receiving XL184
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
| Castrate-resistant Prostate Cancer | — | UNRESOLVED | — |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cabozantinib | Drug | Cabozantinib | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzyme inhibitor therapy)
- description
- Patients receive cabozantinib PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: cabozantinib
- Other: laboratory biomarker analysis
- Procedure: magnetic resonance imaging
Primary outcomes (1)
- measure
- Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline
- timeFrame
- baseline, 2 weeks
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available