None listed
Conditions
Brief summary
The purpose of this study is to see if there is a difference in cognitive decline between elderly patients treated with two common prostate cancer medications (enzalutamide and abiraterone acetate). Who is it for? You may be eligible for this study if you are a male aged 75 or over, and have a diagnosis of metastatic prostate cancer (cancer that has spread outside the prostate). Study details Participants in this study will be randomised by chance (like flipping a coin) into two groups. Both groups will receive one of two standard treatments. One group will receive Abiraterone acetate and a steroid as tablets and the other group will receive Enzalutamide as tablets. Both groups will have their treatment daily until their doctor decides they should stop. As part of this study, participants will answer questionnaires about their ability to think, learn and memorise (cognition), their mood status and their risk of falling. They will also consent to researchers accessing their medical records for information about their cancer. It is hoped this research will clarify if one of these medications has less of an impact on cognitive decline, mood or falls risk, which may help doctors in the decision of what medication to use for elderly patients in the future.
Interventions
Participants will be stratified according to previous docetaxel treatment (Yes/No) and then randomised in a 1:1 ratio to one of two treatment arms described below.
Arm A
Abiraterone acetate 1000mg daily plus corticosteroid (dose, mode of administration and frequency/duration of corticosteroid treatment is determined by treating clinician)
Arm B
Enzalutamide 160mg daily
Both treatment arms are standard of care for this cohort of patients. Participants must commence treatment at full dose. Dose
Participants will be stratified according to previous docetaxel treatment (Yes/No) and then randomised in a 1:1 ratio to one of two treatment arms described below. Arm A Abiraterone acetate 1000mg daily plus corticosteroid (dose, mode of administration and frequency/duration of corticosteroid treatment is determined by treating clinician) Arm B Enzalutamide 160mg daily Both treatment arms are standard of care for this cohort of patients. Participants must commence treatment at full dose. Dose-adjustments or delays will be permitted at any other time point, as determined by the treating clinician. a) The duration of the intervention is 11-13 weeks. Treatment may continue past this point as participants will continue with standard of care as determined by their treating clinician. No assessments will be made after 13 weeks post randomisation. b) The mode of administration of Abiraterone acetate and Enzalutamide is via oral tablet. c) Adherence to the intervention will not be monitored however, cessation of treatment prior to 13 weeks post randomisation will be recorded.
Sponsors
Walter and Eliza Hall Institute for Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age greater than or equal to 75 years • Diagnosis of metastatic castration-resistant prostate carcinoma • Eligible for PBS-subsidised therapy with abiraterone or enzalutamide • Suitable to receive full dose therapy • Able to take oral medications • Able to complete telephone interviews
Exclusion criteria
Previous systemic therapy for CRPC other than docetaxel. Contraindication to abiraterone therapy include but are not limited to: Uncontrolled hypertension. Clinically significant ischemic heart disease or congestive cardiac failure Significant hepatic dysfunction including chronic liver disease or active viral hepatitis; ALT or AST greater than or equal to 2.5 times upper limit of normal range or greater than or equal to 5 times upper limit of normal in presence of liver metastases. Pituitary or adrenal dysfunction. Contraindication to corticosteroids. Contraindication to enzalutamide therapy include but are not limited to: Previous seizures or a condition that confers a predisposition to seizures. History of clinically significant neuropsychiatric event. Clinically significant cognitive impairment.
Outcome results
None listed