Registry-based Study of Enzalutamide vs Abiraterone assessing cognitive function in ELderly patients with Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Metastatic Castration-Resistant Prostate CancerCognitive declineDepressionCancer - ProstateMental Health - Depression
- Registration Number
- ACTRN12620000463976
- Lead Sponsor
- Walter and Eliza Hall Institute for Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 200
•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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive decline incidence<br>The proportion of patients with a higher Blessed Orientation-Memory-Cognition test score (by 1 or more points) at 12 (+/- 1) weeks of treatment as compared to baseline.[Participants will be assessed at baseline (within +/- 7 days of treatment commencing) and after 12 weeks (+/- 1 week) of treatment.];Depression rate.<br>The proportion of patients with depression, as determined by the Geriatric Depression Scale tool as a score > 5 at 12 (+/- 1) weeks of treatment as compared to baseline.[Participants will be assessed at baseline (within +/- 7 days of treatment commencing) and after 12 weeks (+/- 1 week) of treatment.];Falls rate.<br>The proportion of patients who experience at least one fall during the first 12 weeks following randomisation, as determined by the Falls Risk Questionnaire. [Participants will be assessed at baseline (within +/- 7 days of treatment commencing) and after 12 weeks (+/- 1 week) of treatment.]
- Secondary Outcome Measures
Name Time Method Overall survival (death from any cause).[The interval from date of randomisation to the date of death from any cause; or censoring at the date of most recent follow-up where the patient was known to be alive.];Prostate Specific Antigen response rate as assessed by blood test for PSA level.<br>[The proportion of patients with 50% reduction in PSA at any time following randomisation up to 12 weeks post randomisation, compared to baseline level, with baseline defined as within (+/-) 7 days prior to commencing study treatment.]