The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels. Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer
Macquarie University
North Ryde, New South Wales, Australia
RECRUITINGThe proportion of patients who have an improvement in cognition/ fatigue symptoms
The primary endpoint is an improvement in the fatigue and cognition symptoms. Improvement will be de ned as the patient answering 'Better' in the cognition/ fatigue question at the lowest dose of enzalutamide.
Time frame: 1 year post enrolment
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