Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker ‐ Drug Exposure ‐ as a Predictor for Drug Response in Patients With mCRPC

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Optimizing Abiraterone (Zytiga®) Therapy by Exploring the Relation Between an Early Biomarker ‐ Drug Exposure ‐ as a Predictor for Drug Response in Patients With mCRPC

Condition: Metastatic Castration Resistant Prostate Cancer

Intervention:

  • Other: Abiraterone Acetate

Purpose: 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

Clinical Trials Identifier NCT 8-digits: NCT02426333

Sponsor: Radboud University

Primary Outcome Measures:

  • Measure: abiraterone AUC
  • Time Frame: 6 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: biomarkers: relation between biomarkers and treatment response
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: biomarker reduction
  • Time Frame: 6 months
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: January 2016

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Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

Contact:

  • Nielka van Erp, PharmD, PhD
  • +31243616405

Locations:

  • Jeroen Bosch Ziekenhuis
  • Den Bosch Netherlands
  • Canisius Wilhelmina Ziekenhuis
  • Nijmegen Netherlands
  • Radboud UMC
  • Nijmegen Netherlands

View trial on ClinicalTrials.gov

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