Clinical trial · Observational
Optimizing Abiraterone Therapy
Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker - Drug Exposure - as a Predictor for Drug Response in Patients With mCRPC
NCT02426333CI-TRIAL-00040602OPTIMUMcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abiraterone Acetate | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Abiraterone Acetate
- description
- abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study
- interventionNames
- Other: Abiraterone Acetate
Primary outcomes (1)
- measure
- abiraterone AUC
- timeFrame
- 6 months
Secondary outcomes (2)
- measure
- biomarkers: relation between biomarkers and treatment response
- timeFrame
- 6 months
- description
- relation between biomarkers and treatment response
- measure
- biomarker reduction
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * other anticancer therapies * potent CYP3A4 inducers * herbal medicine that could interfere with abiraterone exposure
References
Publications (0)
Data not yet available
No reference posted for this study.