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

Launched by DEVENTER ZIEKENHUIS · May 23, 2025

Keywords

ClinConnect Summary

The ENABLE Study is a clinical trial looking at how a cancer medication called abiraterone affects the way the body processes oxycodone, a pain relief medication, in men with prostate cancer. Prostate cancer can often spread to the bones, causing pain that needs strong medications like oxycodone to manage. By understanding how abiraterone influences oxycodone metabolism, researchers hope to improve pain management for patients.

To participate in this study, men aged 18 and older must have a diagnosis of prostate cancer and be treated with abiraterone for at least 10 days. Participants will be divided into two groups: one group will receive abiraterone while the other will not. It’s important that potential participants haven’t used certain pain medications or have specific health conditions that could affect the study. Those who join will undergo assessments to see how well oxycodone works for them while taking abiraterone. This study is currently recruiting participants, so it’s a great opportunity for eligible men to contribute to important research that may enhance pain management for others in the future.

Gender

MALE

Eligibility criteria

• 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.