Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)

Recruiting now · Phase 4

Conditions studied: Prostate Cancer, Pain Cancer

In brief

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.

Key facts

Study ID

NCT07001709

Run by

Deventer Ziekenhuis

People needed

29

Starts

2024-04-12

Expected to finish

2026-01-30

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

• Deventer Ziekenhuis — Deventer, Overijssel, Netherlands (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.