Broad Health Condition Cancer
Specific Health ConditionProstate
Ashford Cancer Centre: Adelaide Cancer Centre - Kurralta Park
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Border Medical Oncology - Albury
Goulburn Valley Health - Shepparton campus - Shepparton
Peter MacCallum Cancer Centre - Melbourne
5037 - Kurralta Park
3550 - Bendigo
2640 - Albury
3630 - Shepparton
3000 - Melbourne
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.
Key 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
Minimum age75 Years
Key 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.
Sponsor Primary Sponsor Type: Other
Primary Sponsor Name: Walter and Eliza Hall Institute for Medical Research
Primary Sponsor Address: 1G Royal Parade, Parkville Victoria 3052
Primary Sponsor Country: Australia
Contact person for information and recruitmentDr
WEHI 1G Royal Parade Parkville Victoria 3052.