Is monitoring of plasmalevels of abiraterone a possible predictor for the response to Abiraterone treatment, in patients with metastatic prostate cancer?
- Conditions
- Metastatic Castration Resistant Prostate Cancer (mCRPC)MedDRA version: 19.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004513-90-NL
- Lead Sponsor
- Radboud UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- Not specified
- 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
*definition of CRPC according to EAU guidelines 2014
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40
The study objective is to explore the effect of abiraterone exposure on treatment and biomarker response in group of patients treated with abiraterone acetate in agreement with the drug label. Therefore the exclusion criteria as listed in the package insert will be used in this study. Additionally, patients are not allowed to be treated with other anticancer therapies, potent CYP3A4 inhibitors or inducers and herbal medicine that could interfere with abiraterone exposure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method