NCT02471469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2019

Enrollment Period

3.4 years

First QC Date

April 14, 2015

Last Update Submit

October 16, 2020

Conditions

Metastatic Castration Resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Relation between biomarker response and therapeutic response

    6 months

Secondary Outcomes (1)

  • Relation between drug exposure, biomarker and therapeutic response

    6 months

Interventions

Enzalutamide, 160mg, 40 mg soft capsules, once dailyDRUG

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

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chemotherapy naive patients with metastatic CRPC

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Radboud UMC

Nijmegen, 6500HB, Netherlands

Location

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 32408351RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Interventions

enzalutamide

Study Officials

  • Nielka van Erp, PharmD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2015

First Posted

June 15, 2015

Study Start

October 1, 2015

Primary Completion

February 13, 2019

Study Completion

August 1, 2019

Last Updated

October 19, 2020

Record last verified: 2019-09

Locations

NL(3)