Prostate Cancer
Conditions
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
Interventions
DRUGEnzalutamide
Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer
Sponsors
Macquarie University, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with prostate cancer who have commenced enzalutamide within 3 months 2. Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide) 3. Receiving enzalutamide before or after docetaxel 4. Patients may have hormone-sensitive or castrate resistant disease 5. Patients may have metastatic (M1) or non-metastatic (M0) disease 6. Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide
Exclusion criteria
1. Clinical dementia 2. Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines. 3. Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors. 4. Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry. 5. Diagnosed with sleep apnoea 6. Brain metastases, prior seizures, drugs that significantly reduce seizure threshold. 7. Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients who have an improvement in cognition/ fatigue symptoms | 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. |
Countries
Australia
Contacts
Primary ContactProfessor Gurney
Backup ContactHung Tran
Outcome results
None listed