None listed
Conditions
Brief summary
The primary purpose of this trial is to determine effect of enzalutamide dose reduction on fatigue, cognition, and drug trough levels in patients with prostate cancer Who is it for? You may be eligible to join this study if you are a male aged 18 years or above, have prostate cancer who have commenced enzalutamide within 3 months. Study details All patients will be receiving standard dose enzalutamide (160mg daily). If patients experiences a Grade 3 toxicity or an intolerable side effect, enzalutamide will be withheld for one week or until symptoms improve to at least Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg). Dose reduction will be undertaken in 40mg increments, depending on level of cognition and fatigue impairment. Total duration of the intervention period is at the discretion of the investigator. Fatigue and cognition levels will be assessed weekly and blood samples will be collected every four weeks. We hope that this study will improve the individualisation of the enzalutamide treatment by tailoring the doses to each person's needs
Interventions
Patients will be receiving standard dose enzalutamide (160mg daily) as determined by treating physician until disease progression or intolerance
If the patient experiences a greater than or equal to Grade 3 toxicity (as per CTCAE guidelines) withhold enzalutamide for one week or until symptoms improve to at least Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg) at the discretion of the investigator
Fatigue and cognition are assessed once every 4-8 weeks for the duration of
Patients will be receiving standard dose enzalutamide (160mg daily) as determined by treating physician until disease progression or intolerance If the patient experiences a greater than or equal to Grade 3 toxicity (as per CTCAE guidelines) withhold enzalutamide for one week or until symptoms improve to at least Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg) at the discretion of the investigator Fatigue and cognition are assessed once every 4-8 weeks for the duration of treatment depending on stability of dosage Dose reduction will be undertaken in 40mg increments, depending on level of cognition and fatigue impairment at the discretion of the investigator or ceased altogether Intervention adherence will not be formally assessed in this study Patients will be followed up for 12 months for the purposes of this study
Sponsors
Macquarie University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
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.
Outcome results
None listed