ACTRN12620000463976
Recruiting
Phase 4
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.
Walter and Eliza Hall Institute for Medical Research0 sites200 target enrollmentApril 9, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Metastatic Castration-Resistant Prostate Cancer
- Sponsor
- Walter and Eliza Hall Institute for Medical Research
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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