Trial purpose
Cancer treatment; Side effect and wellbeing
Tumor type
Genitourinary
Age
75+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two treatment groups. Both groups will receive one of two standard treatments for metastatic castration-resistant prostate cancer.
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 the 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 eldery patients in the future.
Conditions
This trial is treating people with metastatic castration-resistant prostate cancer
Eligibility
Inclusion
• 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 interview
Exclusion
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.
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Walter and Eliza Hall Institute for Medical Research
Scientific Title
A prospective, open-label, multi-centre, registry-based randomised clinical trial comparing the cognitive impact of standard-of-care treatments in men aged 75 years or older that have metastatic castration-resistant prostate cancer.
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