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CompletedNCT02471469ILUMINATEUpdated Oct 19, 2020

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

An observational study in Metastatic Castration Resistant Prostate Cancer, sponsored by Radboud University Medical Center. Completed at 3 sites in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Radboud University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Metastatic Castration Resistant Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 40 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

chemotherapy naive patients with metastatic CRPC

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

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • DrugEnzalutamide, 160mg, 40 mg soft capsules, once daily

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

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What researchers measure

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

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Study locations

3 sites
  • Jeroen Bosch Ziekenhuis
    Den Bosch, Netherlands
  • Radboud UMC
    Nijmegen, 6500HB, Netherlands
  • Canisius Wilhelmina Ziekenhuis
    Nijmegen, Netherlands
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References and documents

Publications

  • 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. PubMed 32408351 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02471469
Lead sponsor
Radboud University Medical Center
Collaborators
Astellas Pharma Europe B.V.
Responsible party
Sponsor
First posted
Jun 15, 2015
Start date
Oct 2015
Primary completion
Feb 13, 2019
Completion
Aug 1, 2019
Last update
Oct 19, 2020

Study contacts

Nielka van Erp, PharmD, PhD
principal investigator · Radboud University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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