Status:
RECRUITING
Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)
Lead Sponsor:
Deventer Ziekenhuis
Conditions:
Prostate Cancer
Pain Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief Summary
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 pro...
Detailed Description
Rationale: Oxycodone is an opioid receptor agonist metabolized primarily by CYP3A4, and to a lesser extent by CYP2D6. Abiraterone is an androgen biosynthesis inhibitor prescribed to men with castratio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT07001709
Start Date
April 12 2024
End Date
January 30 2026
Last Update
June 3 2025
Active Locations (1)
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1
Deventer Ziekenhuis
Deventer, Overijssel, Netherlands, 7416SE