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OpenTrials
Completed

NCT Number: NCT02471469

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

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.

Completed

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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enzalutamide, 160mg, 40 mg soft capsules, once daily

Drug

Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label

Primary outcomes

  1. Relation between biomarker response and therapeutic response

    Time frame: 6 months

Secondary outcomes

  1. Relation between drug exposure, biomarker and therapeutic response

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Astellas Pharma Europe B.V.

Registry information

Official study title

Personalizing Enzalutamide Therapy by Understanding the Relation Between the Decrease in the Expression Profile of a Panel of Preselected microRNAs, Tumor Related mRNAs and Treatment Response in Chemotherapy Naive Patients With mCRPC

Acronym: ILUMINATE

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 15, 2015
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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