Metastatic Castration Resistant Prostate Cancer
Conditions
Brief summary
The primary aim is to show whether a reduction in tumor related mRNAs and a panel of selected miRNAS can be used to personalize enzalutamide therapy. Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.
Interventions
DRUGEnzalutamide, 160mg, 40 mg soft capsules, once daily
Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label
Sponsors
Astellas Pharma Europe B.V.
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male patients with chemotherapy naive metastatic castration resistant prostate cancer\* * Age at least 18 years * Patients from who it is possible to collect blood samples * Patient who are able and willing to give written informed consent prior to screening and enrollment * Life expectancy of \> 6 months * Measurable disease \*definition of CRPC according to EAU guidelines 2014
Exclusion criteria
* None The study objective is to explore the effect of enzalutamide on biomarker exposure in a group of patients treated with enzalutamide in agreement with the drug label. Therefore no strict
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relation between biomarker response and therapeutic response | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Relation between drug exposure, biomarker and therapeutic response | 6 months |
Countries
Netherlands
Outcome results
None listed