ILUMINATE: Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
Sponsor
Radboud University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02471469
Collaborator
Astellas Pharma Europe B.V. (Industry)
40
3
46
13.3
0.3
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official 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
Actual Study Start Date
:
Oct 1, 2015
Actual Primary Completion Date
:
Feb 13, 2019
Actual Study Completion Date
:
Aug 1, 2019
Outcome Measures
Primary Outcome Measures
- Relation between biomarker response and therapeutic response [6 months]
Secondary Outcome Measures
- Relation between drug exposure, biomarker and therapeutic response [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jeroen Bosch Ziekenhuis | Den Bosch | Netherlands | ||
| 2 | Radboud UMC | Nijmegen | Netherlands | 6500HB | |
| 3 | Canisius Wilhelmina Ziekenhuis | Nijmegen | Netherlands |
Sponsors and Collaborators
- Radboud University Medical Center
- Astellas Pharma Europe B.V.
Investigators
- Principal Investigator: Nielka van Erp, PharmD, PhD, Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT02471469
Other Study ID Numbers:
- AKF UMCN 14.17
First Posted:
Jun 15, 2015
Last Update Posted:
Oct 19, 2020
Last Verified:
Sep 1, 2019
Additional relevant MeSH terms: