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

NCT07001709 | Recruiting Phase 4

• 2 other identifiers: ME23-422023-505705-17-00
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 prostate cancer - affects the pharmacokinetics of oxycodone in order to improve pain management.

Conditions

Prostate Cancer; Pain Cancer

Outcome Measures

Primary Outcomes (3)

• Cmax Oxycodone

  Maximum measured concentration of oxycodone

  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

  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.

  From 0 to 8 hours after ingestion of oxycodone

Secondary Outcomes (6)

• Cmax noroxycodone

  Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)

• AUC0-8h noroxycodone

  From 0 to 8 hours after ingestion of oxycodone

• Cmax oxymorphone

  Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)

• AUC0-8h oxymorphone

  From 0 to 8 hours after ingestion of oxycodone

• Cmax noroxymorphone

  Measured at one of the time points (t= 0.5, 1, 1.5, 2, 3, 5, 8 hours)

Study Arms (2)

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.

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.

Drug: Oxycodone oral capsule 15 mg; Drug: Abiraterone Acetate Tablets 500 mg

Interventions

Oxycodone oral capsule 15 mg DRUG

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

Abiraterone group; Control group

Abiraterone Acetate Tablets 500 mg DRUG

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

Abiraterone group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male patients with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Deventer Ziekenhuis: lead

Study Sites (1)

Deventer Ziekenhuis

Deventer, Overijssel, 7416SE, Netherlands

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Cancer Pain

Interventions

Oxycodone; Abiraterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Androstenes; Androstanes; Steroids; Fused-Ring Compounds

Central Study Contacts

Frank Jansman, Prof. dr.

CONTACT

+31570 53 60 00; f.jansman@dz.nl

Lotte Hulskotte, drs.

CONTACT

+31631451719; l.hulskotte@dz.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: June 3, 2025
• Study Start: April 12, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 30, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

NL (1)