Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
Completed
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Registration Number
- NCT02471469
- Lead Sponsor
- Radboud University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
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
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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 exclusion criteria will be used in this study
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relation between biomarker response and therapeutic response 6 months
- Secondary Outcome Measures
Name Time Method Relation between drug exposure, biomarker and therapeutic response 6 months
Trial Locations
- Locations (3)
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands