Optimizing Abiraterone Therapy (OPTIMUM)

September 12, 2019 updated by: Radboud University Medical Center

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Abiraterone Acetate
abiraterone treatment, 1000mg, tablets, once daily, treatment is not adapted for the study
Other: Abiraterone Acetate
Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
abiraterone AUC
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomarkers: relation between biomarkers and treatment response
Time Frame: 6 months
relation between biomarkers and treatment response
6 months
biomarker reduction
Time Frame: 6 months
To explore the if reduction in biomarkers is related to treatment response after three and six months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Janssen-Cilag Ltd.

Investigators

  • Principal Investigator: Jack Schalken, PhD, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

April 24, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

March 27, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (ESTIMATE)

April 24, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 12, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCN AKF-14.07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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