Actively Recruiting

Phase 4
Age: 18Years +
MALE
NCT07001709

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

Led by Deventer Ziekenhuis · Updated on 2025-06-03

29

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed prostate cancer
  • Male aged 18 years or older
  • For abiraterone group: treated with 1000 mg abiraterone once daily for at least 10 days
  • For control group: not treated with 1000 mg abiraterone once daily for at least 10 days
Not Eligible

You will not qualify if you...

  • Use of short-acting oxycodone within 48 hours before the study day
  • Use of long-acting oxycodone within 96 hours before the study day
  • Use of other opioids within 14 days before the study day
  • Use of medications that interact with oxycodone pharmacokinetics or pharmacodynamics
  • Dose reduction or treatment interruption within 10 days before the study day in control arm
  • Treatment with abiraterone within 10 days before the study day in abiraterone arm
  • Body mass index outside 18 to 30 kg/m2
  • Hypersensitivity to oxycodone
  • Diarrhea
  • Any abnormality or active/symptomatic viral hepatitis or chronic liver disease (Child-Pugh B or C)
  • Known liver metastases affecting drug metabolism
  • CYP3A4 or CYP2D6 polymorphism
  • Moderate to severe renal dysfunction (GFR <60 ml/min/1.73m2)
  • Significant respiratory depression needing oxygen therapy or hypoventilation (respiratory rate <12/min)
  • Hypercapnia (venous pCO2 outside 5.5 to 6.7 or pH outside 7.30 to 7.40)
  • History of bronchial asthma, chronic obstructive pulmonary disease, or pulmonary heart disease
  • Started first chemotherapy cycle within 2 weeks before the study day
  • Major surgery within 1 month before screening or planned surgery
  • History of drug abuse
  • Receiving opioid substitution therapy or suffering opioid withdrawal
  • Clinically significant gastrointestinal disease
  • Contraindication for blood sampling
  • Unable to swallow oral solid dosage forms whole with water
  • Participation in another clinical trial within 30 days or 5 half-lives prior to enrollment
  • Previous gastric bypass or gastric band surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands, 7416SE

Actively Recruiting

Loading map...

Research Team

F

Frank Jansman, Prof. dr.

CONTACT

L

Lotte Hulskotte, drs.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here