Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

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

Q: What is the NCT07001709 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT07001709?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07001709?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

The Effect of Abiraterone on the Metabolism of Oxycodone

Determining the Effect of Abiraterone on the Metabolism of Oxycodone in Men With Prostate Cancer (the ENABLE Study) (NCT07001709) is a Phase 4 interventional studying Prostate Cancer and Pain Cancer, sponsored by Deventer Ziekenhuis. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 29 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Oxycodone oral capsule 15 mg

Single dose of 15 mg oxycodone direct release (both arm 1 and arm 2)

DRUG

Abiraterone Acetate Tablets 500 mg

Abiraterone group: 1000 mg abiraterone acetate (at steady state)

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07001709), the sponsor (Deventer Ziekenhuis), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07001709 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07001709?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07001709?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07001709. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07001709. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.