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OpenTrials
Completed

NCT Number: NCT02426333

Optimizing Abiraterone Therapy

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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Key information

Conditions

Metastatic Castration Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abiraterone acetate

Other

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

Primary outcomes

  1. abiraterone AUC

    Time frame: 6 months

Secondary outcomes

  1. biomarkers: relation between biomarkers and treatment response

    Time frame: 6 months

    relation between biomarkers and treatment response

  2. biomarker reduction

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Janssen-Cilag Ltd.

Registry information

Official study title

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

Acronym: OPTIMUM

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2015
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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