Optimizing Abiraterone Therapy

Radboud University Medical Center56 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

Abiraterone AcetateOTHER

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

Radboud UMC

Nijmegen, Netherlands

Outcomes

Primary Outcomes

abiraterone AUC

Time frame: 6 months

Secondary Outcomes

biomarkers: relation between biomarkers and treatment response

relation between biomarkers and treatment response

Time frame: 6 months

biomarker reduction

To explore the if reduction in biomarkers is related to treatment response after three and six months

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.