Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- The proportion of patients who have an improvement in cognition/ fatigue symptoms
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
Enzalutamide
Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide
Intervention: Enzalutamide (Drug)
Outcomes
Primary Outcomes
The proportion of patients who have an improvement in cognition/ fatigue symptoms
Time Frame: 1 year post enrolment
The primary endpoint is an improvement in the fatigue and cognition symptoms. Improvement will be de ned as the patient answering 'Better' in the cognition/ fatigue question at the lowest dose of enzalutamide.
Secondary Outcomes
No secondary outcomes reported