Prostate CancerPhase 4ENABLENCT07001709
Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study)
A Phase 4 study testing Oxycodone oral capsule 15 mg and Abiraterone Acetate Tablets 500 mg in people with Prostate Cancer and Pain Cancer, run by Deventer Ziekenhuis at 1 site in Netherlands.
Trial 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 prostate cancer - affects the pharmacokinetics of oxycodone in order to improve pain management. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Pain Cancer
- What is being tested?
- Oxycodone oral capsule 15 mg and Abiraterone Acetate Tablets 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2024to 30 Jan 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Deventer Ziekenhuis
Deventer, Overijssel, 7416SE
Frank Jansman, prof. dr., +31570 53 60 00, f.jansman@dz.nl
Lotte Hulskotte, drs., +3131451719, l.hulskotte@dz.nl
About this study
Official title: The Effect of Abiraterone on the Metabolism of Oxycodone
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.
Read the 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 castration resistant prostate cancer (CRPC). The ENABLE study is a follow-up to the ENZYME study in which it was described that enzalutamide increases oxycodone metabolism in patients with CRPC. It is expected that concomitant use of abiraterone has no clinically relevant effect on oxycodone's plasma concentration since it solely inhibits CYP2D6. Therefore, discontinuing abiraterone treatment is not expected to result in toxicity. This might positively affect pain management and pharmacovigilance in patients with CRPC.
Objective: To investigate the effect of abiraterone on the pharmacokinetics (PK) of oxycodone following a single dose of 15 mg normal-release oxycodone in men with prostate cancer.
Trial design: A prospective, open-label, two-arm parallel clinical study.
Subjects will visit the hospital once for approximately nine hours. After screening for hypercapnia, subjects will receive one oral dose of 15 mg (10 mg and 5 mg capsules) normal-release oxycodone. In total, nine blood samples will be collected during the day for the control group and ten blood samples for the abiraterone group. Seven blood samples will be collected at predetermined times (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours) in order to analyze the metabolism of oxycodone. One blood sample will be collected to determine abiraterone serum trough concentrations (abiraterone arm). In addition, two blood samples will be collected for patient characteristics, including one sample for genotyping of CYP3A4 and CYP2D6.
- Conditions
- Prostate Cancer, Pain Cancer
- Being tested
- Oxycodone oral capsule 15 mg, Abiraterone Acetate Tablets 500 mg
- Medical subject headings
- Prostatic Neoplasms, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone oral capsule 15 mgDrug
Single dose of 15 mg oxycodone direct release (both arm 1 and arm 2)
Abiraterone Acetate Tablets 500 mgDrug
Abiraterone group: 1000 mg abiraterone acetate (at steady state)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Receive 15 mg oxycodone (direct release) without the use of abiraterone. The plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone is measured. In addition, one blood sample is drawn for determine patient characteristics and genotyping of CYP3A4 and CYP2D6 is determined. Receives: Drug: Oxycodone oral capsule 15 mg |
| Abiraterone group | Other | Receive 15 mg oxycodone (direct release) and abiraterone. The plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone is measured. In addition, one blood sample is drawn for determine patient characteristics, the serum through concentration of abiraterone and genotyping of CYP3A4 and CYP2D6 are determined. Receives: Drug: Oxycodone oral capsule 15 mg; Drug: Abiraterone Acetate Tablets 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax Oxycodone
Maximum measured concentration of oxycodone
Measured: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
T1/2 oxycodone
Measured half-life of oxycodone
Measured: t= 0.5, 1, 1.5, 2, 3, 5, 8 hours
AUC0-8h oxycodone
Area under the curve of oxycodone from 0 to 8 hours after ingestion of oxycodone.
Measured: From 0 to 8 hours after ingestion of oxycodone
Secondary outcomes (6)
Cmax noroxycodone
Maximum measured concentration of noroxycodone
Measured: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
AUC0-8h noroxycodone
Area under the curve of noroxycodone from 0 to 8 hours after ingestion of oxycodone.
Measured: From 0 to 8 hours after ingestion of oxycodone
Cmax oxymorphone
Maximum measured concentration of oxymorphone
Measured: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
AUC0-8h oxymorphone
Area under the curve of oxymorphone from 0 to 8 hours after ingestion of oxycodone.
Measured: From 0 to 8 hours after ingestion of oxycodone
Cmax noroxymorphone
Maximum measured concentration of noroxymorphone
Measured: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
AUC0-8h noroxymorphone
Area under the curve of noroxycodone from 0 to 8 hours after ingestion of oxycodone.
Measured: From 0 to 8 hours after ingestion of oxycodone
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start12 Apr 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deventer Ziekenhuis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001709
- Sponsor's protocol ID
- ME23-42
- Other IDs
- 2023-505705-17-00, 2023
- Acronym
- ENABLE
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Abiraterone on the Metabolism of Oxycodone
- ClinicalTrials.gov ID
- NCT07001709
- Acronym / sponsor ID
- ENABLE / ME23-42
- Conditions
- Prostate Cancer, Pain Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Deventer ZiekenhuisUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 castration resistant prostate cancer (CRPC). The ENABLE study is a follow-up to the ENZYME study in which it was described that enzalutamide increases oxycodone metabolism in patients with CRPC. It is expected that concomitant use of abiraterone has no clinically relevant effect on oxycodone's plasma concentration since it solely inhibits CYP2D6. Therefore, discontinuing abiraterone treatment is not expected to result in toxicity. This might positively affect pain management and pharmacovigilance in patients with CRPC.
Objective: To investigate the effect of abiraterone on the pharmacokinetics (PK) of oxycodone following a single dose of 15 mg normal-release oxycodone in men with prostate cancer.
Trial design: A prospective, open-label, two-arm parallel clinical study.
Subjects will visit the hospital once for approximately nine hours. After screening for hypercapnia, subjects will receive one oral dose of 15 mg (10 mg and 5 mg capsules) normal-release oxycodone. In total, nine blood samples will be collected during the day for the control group and ten blood samples for the abiraterone group. Seven blood samples will be collected at predetermined times (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours) in order to analyze the metabolism of oxycodone. One blood sample will be collected to determine abiraterone serum trough concentrations (abiraterone arm). In addition, two blood samples will be collected for patient characteristics, including one sample for genotyping of CYP3A4 and CYP2D6.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: Oxycodone oral capsule 15 mgReceive 15 mg oxycodone (direct release) without the use of abiraterone. The plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone is measured. In addition, one blood sample is drawn for determine patient characteristics and genotyping of CYP3A4 and CYP2D6 is determined. |
| Abiraterone group | Other | Drug: Oxycodone oral capsule 15 mg, Drug: Abiraterone Acetate Tablets 500 mgReceive 15 mg oxycodone (direct release) and abiraterone. The plasma concentration of oxycodone, noroxycodone, oxymorphone and noroxymorphone is measured. In addition, one blood sample is drawn for determine patient characteristics, the serum through concentration of abiraterone and genotyping of CYP3A4 and CYP2D6 are determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone oral capsule 15 mgSingle dose of 15 mg oxycodone direct release (both arm 1 and arm 2) | Drug | Abiraterone group, Control group |
| Abiraterone Acetate Tablets 500 mgAbiraterone group: 1000 mg abiraterone acetate (at steady state) | Drug | Abiraterone group |
Primary outcome
Cmax Oxycodone
Time frame: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
Maximum measured concentration of oxycodone
T1/2 oxycodone
Time frame: t= 0.5, 1, 1.5, 2, 3, 5, 8 hours
Measured half-life of oxycodone
AUC0-8h oxycodone
Time frame: From 0 to 8 hours after ingestion of oxycodone
Area under the curve of oxycodone from 0 to 8 hours after ingestion of oxycodone.
6 secondary outcomes
Cmax noroxycodone
Time frame: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
AUC0-8h noroxycodone
Time frame: From 0 to 8 hours after ingestion of oxycodone
Cmax oxymorphone
Time frame: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
AUC0-8h oxymorphone
Time frame: From 0 to 8 hours after ingestion of oxycodone
Cmax noroxymorphone
Time frame: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)
AUC0-8h noroxymorphone
Time frame: From 0 to 8 hours after ingestion of oxycodone
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone oral capsule 15 mg and Abiraterone Acetate Tablets 500 mg in people with Prostate Cancer and Pain Cancer, run by Deventer Ziekenhuis at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank Jansman, Prof. dr. (+31570 53 60 00, f.jansman@dz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax Oxycodone (time frame: Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.