Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response (ILUMINATE)

Radboud University Medical Center

Status: Completed

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Drug: Enzalutamide, 160mg, 40 mg soft capsules, once daily

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02471469

AKF UMCN 14.17

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 exclusion criteria will be used in this study