Optimizing Abiraterone Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2019-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Castration Resistant Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Abiraterone Acetate

abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study

Abiraterone Acetate

Intervention Type OTHER

Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)

Interventions

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Abiraterone Acetate

Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)

Intervention Type OTHER

Eligibility Criteria

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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