Optimizing abiraterone (zytiga®)therapy by exploring the relation between an early biomarker-drug exposure-as a predictor for drug response in patients with mCRPC (OPTIMUM study)
- Conditions
- metastatic castration resistant prostate cancer10027655
- Registration Number
- NL-OMON44680
- Lead Sponsor
- Afdeling Apotheek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
* 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 * OR * who have been treated upfront with 6 cycles of docetaxel: conform the Chaarted or Stampede trials
*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
Patients will be treated with abiraterone acetate in agreement with the drug label. Therefore the contra*indications of the drug label will be respected and no addi*tional strict exclusion criteria will be used in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To describe the relation between (early)drug exposure and therapeutical<br /><br>response</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Delta changes (%) of the biomarkers from baseline measurement<br /><br>- To describe the relation between biomarker and therapeutical response<br /><br>- To describe the relation between biomarker and drug exposure</p><br>