Metastatic Castration Resistant Prostate Cancer Clinical Trial
— ILUMINATEOfficial 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
| NCT number | NCT02471469 |
| Other study ID # | AKF UMCN 14.17 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2015 |
| Est. completion date | August 1, 2019 |
| Verified date | September 2019 |
| Source | Radboud University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | August 1, 2019 |
| Est. primary completion date | February 13, 2019 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Jeroen Bosch Ziekenhuis | Den Bosch | |
| Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
| Netherlands | Radboud UMC | Nijmegen |
| Lead Sponsor | Collaborator |
|---|---|
| Radboud University | Astellas Pharma Europe B.V. |
Netherlands,
Benoist GE, van Oort IM, Boerrigter E, Verhaegh GW, van Hooij O, Groen L, Smit F, de Mol P, Hamberg P, Dezentjé VO, Mehra N, Gerritsen W, Somford DM, van Erp NPH, Schalken JA. Prognostic Value of Novel Liquid Biomarkers in Patients with Metastatic Castrat — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relation between biomarker response and therapeutic response | 6 months | ||
| Secondary | Relation between drug exposure, biomarker and therapeutic response | 6 months |
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