Optimizing Abiraterone Therapy
OPTIMUM
Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC
1 other identifier
observational
56
1 country
3
Brief Summary
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Typical duration for all trials
3 active sites
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
March 27, 2015
CompletedFirst Posted
Study publicly available on registry
April 24, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedSeptember 13, 2019
September 1, 2019
3.3 years
March 27, 2015
September 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
abiraterone AUC
6 months
Secondary Outcomes (2)
biomarkers: relation between biomarkers and treatment response
6 months
biomarker reduction
6 months
Study Arms (1)
Abiraterone Acetate
abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study
Interventions
Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)
Eligibility Criteria
Male patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
You may qualify if:
- Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
- Age ≥18 years
- Feasible to collect blood samples from
- Life expectancy of \> 6 months
- Measurable disease
- Able and willing to give written informed consent prior to screening and enrollment
You may not qualify if:
- other anticancer therapies
- potent CYP3A4 inducers
- herbal medicine that could interfere with abiraterone exposure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Radboud University Medical Centerlead
- Janssen-Cilag Ltd.collaborator
Study Sites (3)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Radboud UMC
Nijmegen, Netherlands
Biospecimen
Blood samples for abiraterone concentrations and also blood samples to assess biomarkers (some contain DNA)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nielka van Erp, PharmD, PhD
Radboud University Medical Center
- PRINCIPAL INVESTIGATOR
Jack Schalken, PhD
Radboud University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2015
First Posted
April 24, 2015
Study Start
January 1, 2016
Primary Completion
April 24, 2019
Study Completion
August 1, 2019
Last Updated
September 13, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share