Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorDeventer Ziekenhuis
About this trial
Prostate cancer often leads to bone metastases, which require adequate pain management with opioids such as oxycodone. This study investigates whether abiraterone - a drug used in the treatment of prostate cancer - affects the pharmacokinetics of oxycodone in order to improve pain management.
Eligibility criteria
Qualifiers
Diagnosed prostate cancer;
Males aged 18 years or older;
Treated with abiraterone 1000 mg once daily for at least 10 days (abiraterone arm).
Not treated with abiraterone 1000 mg once daily for at least 10 days (control arm).
Disqualifiers
Use of oxycodone short acting <48 hours, or long acting <96 hours prior to the study day;
Use of other opioids in the 14 days prior to the study day (see also appendix A);
Use of other medication that has pharmacokinetic or pharmacodynamics interactions with oxycodone (see also appendix A);
Arm 1: dose reduction or successive days of treatment interruption within 10 days prior to the study day (arm 1);
Trial design
Treatments tested in this trial
- Oxycodone oral capsule 15 mg
- Abiraterone Acetate Tablets 500 mg
Treatment groups
29 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov