Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
NCT ID: NCT02471469
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2015-10-31
2019-08-01
Brief Summary
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Furthermore the aim is to explore the relation between drug exposure and the decrease in the selected biomarkers and treatment response.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Enzalutamide, 160mg, 40 mg soft capsules, once daily
Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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Astellas Pharma Europe B.V.
INDUSTRY
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Nielka van Erp, PharmD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Countries
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References
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Benoist GE, van Oort IM, Boerrigter E, Verhaegh GW, van Hooij O, Groen L, Smit F, de Mol P, Hamberg P, Dezentje VO, Mehra N, Gerritsen W, Somford DM, van Erp NPH, Schalken JA. Prognostic Value of Novel Liquid Biomarkers in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Enzalutamide: A Prospective Observational Study. Clin Chem. 2020 Jun 1;66(6):842-851. doi: 10.1093/clinchem/hvaa095.
Related Links
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Other Identifiers
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AKF UMCN 14.17
Identifier Type: -
Identifier Source: org_study_id
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