Clinical Trial Details

Registry-based Study of Enzalutamide vs Abiraterone assessing cognitive function in ELderly patients with Metastatic Castration-Resistant Prostate Cancer

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Trial Information

Broad Health Condition Cancer
Mental Health

Specific Health ConditionProstate
Depression

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,SA,VIC

Hospital
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


Postcode
5037 - Kurralta Park
3550 - Bendigo
2640 - Albury
3630 - Shepparton
3000 - Melbourne

Phase of TrialPhase 4

Has the study received ethics approval?Further information iconApproved

Trial 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.
Eligibility

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

GenderMales

Can Healthy volunteers participate?No

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.
Contact details and further information

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

Trial IDACTRN12620000463976

UTNNil

Contact person for information and recruitmentDr
Arsha Anton
WEHI 1G Royal Parade Parkville Victoria 3052.
+61 409146588

Further information iconarsha.anton@monash.edu
Australia