Metastatic Castration Resistant Prostate CancerILUMINATENCT02471469
Personalizing Enzalutamide Therapy by Understanding the Relation Between Tumor mRNAs, miRNAs and Treatment Response
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Radboud University Medical Center at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- Enzalutamide, 160mg, 40 mg soft capsules, once daily
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 3 sitesNetherlands
- Study dates
- Oct 2015to 1 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: chemotherapy naive patients with metastatic CRPC
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Radboud UMC
Nijmegen, 6500HB
Canisius Wilhelmina Ziekenhuis
Nijmegen
About this study
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
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.
- Being tested
- Enzalutamide, 160mg, 40 mg soft capsules, once daily
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide, 160mg, 40 mg soft capsules, once dailyDrug
Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between biomarker response and therapeutic response
Measured: 6 months
Secondary outcomes (1)
Relation between drug exposure, biomarker and therapeutic response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startOct 2015
- Primary completion13 Feb 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Castration Resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Europe B.V.
- Responsible party
- Sponsor
- Investigators
- Nielka van Erp, PharmD, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471469
- Sponsor's protocol ID
- AKF UMCN 14.17
- Acronym
- ILUMINATE
- Status last verified
- Sep 2019
- First submitted
- 14 Apr 2015
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02471469
- Acronym / sponsor ID
- ILUMINATE / AKF UMCN 14.17
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Europe B.V.
- Study start
- Oct 2015 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- chemotherapy naive patients with metastatic CRPC
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzalutamide, 160mg, 40 mg soft capsules, once dailyExclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label | Drug | – |
Primary outcome
Relation between biomarker response and therapeutic response
Time frame: 6 months
1 secondary outcome
Relation between drug exposure, biomarker and therapeutic response
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Results publication: PubMed 32408351Benoist 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.
- paperLink provided by the sponsor.
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Metastatic Castration Resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nielka van Erp, PharmD, PhD principal investigator
Radboud University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration Resistant Prostate Cancer, run by Radboud University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between biomarker response and therapeutic response (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020; AzTrials last refreshed its copy on 4 Nov 2026.