Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

Phase 4

Recruiting

• Conditions: Prostate cancer; 10036958

• Registration Number: NL-OMON53933
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Patient with prostate cancer - Patients who will start treatment with
enzalutamide within label or are on treatment with enzalutamide AND are on
treatment or will start with morphine or opioids and willing and able to switch
to morphine (2 dd extended release equivalent dose) (morphine arm 3) OR are on
treatment with edoxaban (30mg or 60mg OD, according to the label) (edoxaban arm
1) OR - Patients that are on treatment with edoxaban (30 or 60mg OD, according
to the label) (edoxaban arm 2) OR are on treatment or will start with morphine
or opioids and willing and able to switch to morphine (2 dd extended release
equivalent dose) (morphine arm) (morphine arm 4) - Age at least 18 years -
Patient who are able and willing to give written informed consent prior to
screening - Patients from whom it is possible to collect blood samples - Life
expectancy of > 3 months - Stable renal function and renal clearance > 50ml/min

Exclusion Criteria

- Patients who are co-treated with drugs that could interfere with the
metabolism of enzalutamide, edoxaban and/or morphine

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified