Effect of Enzalutamide Dose Reduction on Fatigue Cognition and Drug Trough Levels in Patients With Prostate Cancer

  • STATUS
    Recruiting
  • participants needed
    47
  • sponsor
    Macquarie University, Australia
Updated on 8 November 2020
Investigator
Hung Tran
Primary Contact
Macquarie University (1.3 mi away) Contact
docetaxel
luteinizing hormone-releasing hormone agonist
enzalutamide
gonadorelin

Summary

The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels.

Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide

Details
Treatment Enzalutamide
Clinical Study IdentifierNCT03124615
SponsorMacquarie University, Australia
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have Malignant neoplasm of prostate?
Patients with prostate cancer who have commenced enzalutamide within 3 months
Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide)
Receiving enzalutamide before or after docetaxel
Patients may have hormone-sensitive or castrate resistant disease
Patients may have metastatic (M1) or non-metastatic (M0) disease
Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide

Exclusion Criteria

Clinical dementia
Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines
Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors
Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry
Diagnosed with sleep apnoea
Brain metastases, prior seizures, drugs that significantly reduce seizure threshold
Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry
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