Abiraterone's effect on oxycodone metabolism in men with prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, two-arm parallel study compares oxycodone pharmacokinetics in men with prostate cancer who are taking abiraterone versus those who are not. Each participant receives a single 15 mg dose of immediate-release oxycodone and stays about nine hours at the hospital for serial blood sampling to measure drug levels. The abiraterone arm requires at least 10 days of prior abiraterone treatment while the control arm must not have used abiraterone in the prior 10 days. Results will determine whether abiraterone meaningfully alters oxycodone plasma concentrations and inform pain-management decisions in castration-resistant prostate cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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);
* Arm 2: treatment with abiraterone within 10 days prior to the study day;
* A body mass index (BMI) outside the range of 18 - 30 kg/m2;
* If hypersensitive to oxycodone;
* patients suffering from diarrhea
* If any type of abnormality; active or symptomatic viral hepatitis or chronic liver disease (e.g. classification with Child-Pugh B, Child-Pugh C);
* Known metastases in the liver that would affect drug metabolism;
* Patients with a CYP3A4 or CYP2D6 polymorphism;
* Moderate-severe renal dysfunction (GFR \<60 ml/min/1.73m2) that affects drug metabolism ;
* Subjects with significant respiratory depression resulting in the need of oxygen therapy or objective hypoventilation (respiratory rate \<12/min);
* Hypercapnia (venous pCO2 outside the range of 5.5 - 6.7; pH outside the range 7.30 - 7.40);
* Subjects with, a history of bronchial asthma, chronic obstructive pulmonary disease or pulmonary heart disease;
* Subjects who started their first cycle of chemotherapy during the 2 weeks before the study day;
* Major surgery within 1 month prior to screening or planned surgery;
* A history of drug abuse
* Patients receiving opioid substitution therapy for opioid addiction (e.g. methadone or buprenorphine) and/or suffering from opioid withdrawal
* Patients with evidence of clinically significant gastrointestinal disease;
* Patients who are contraindicated for blood sampling;
* Unable to swallow solid, oral dosage forms whole with water;
* Participation in a clinical trial study at the time of enrolment or within 30 days or 5 half-lives of enrolment, whichever is longer;
* Previous gastric bypass or gastric band surgery.

Where it's running

• Deventer Ziekenhuis
  Deventer, Overijssel, Netherlands Recruiting

Study contacts

• Study coordinator: Frank Jansman, Prof. dr.
• Email: f.jansman@dz.nl
• Phone: +31570 53 60 00

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.