Metastatic Castration Resistant Prostate Cancer
Conditions
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.
Interventions
OTHERAbiraterone Acetate
Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)
Sponsors
Janssen-Cilag Ltd.
Radboud University Medical Center
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| abiraterone AUC | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| biomarkers: relation between biomarkers and treatment response | 6 months | relation between biomarkers and treatment response |
| biomarker reduction | 6 months | To explore the if reduction in biomarkers is related to treatment response after three and six months |
Countries
Netherlands
Outcome results
None listed