Phase 2 N=19 Diagnostic

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

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

Bottom Line

View on ClinicalTrials.gov: NCT01599793 ↗

Enrolled (actual)

Serious AEs

23.5%

Results posted

Mar 2020

Primary outcome: Primary: Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline — 0.026 per minute (or min-1) — p=0.0016

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: cabozantinib (Drug); laboratory biomarker analysis (Other); magnetic resonance imaging (Procedure)
Age: Pediatric, Adult, Older Adult
Sex: Male
Sponsor: University of Chicago
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Functional MRI Metrics Ktrans Between 2 Weeks and Baseline	0.026	0.0016 sig
SECONDARY Association of Progression Free Survival (PFS) With Ktrans and ADC	5.100	—
SECONDARY Changes in Bone Scan Response	-0.43750	0.3291
SECONDARY Correlation of Percent Change in the Functional MRI Metrics to RECIST Tumor Measurements	—	—
SECONDARY Change of PSA Between 12 Weeks and Baseline	453.04	0.2006
SECONDARY Correlation of Percent Change in the Functional MRI Metrics With CTC	—	—
SECONDARY Change in Pain Scale Between 12 Weeks and Baseline	-1.35714	0.5828

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)

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01599793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.