Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Radboud University Medical Center
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Frailᵃ male patients with prostate cancer who will start treatment with enzalutamide within label
Age at least 18 years
Patient who are able and willing to give written informed consent prior to screening
Patients from whom it is possible to collect blood samples
Patients who are willing to answer the questionnaires and test
Life expectancy of \> 6 months
Capable of understanding and answering Dutch tests and questionnaires, as determined by the investigator
ᵃ Frail is defined as:
a score on the comprehensive G8 assessment with cut-off ≤14 points and
score ≥grade 1 for Central Nervous Disorders according to the Common Toxicity Criteria Adverse Event (CTCAE) criteria, of one of the following: Fatigue, Concentration impairment, cognitive disturbance, amnesia, depressed level of consciousness, memory impairment, hypersomnia.
You may not be if
change in dose of opioids/sedatives/benzodiazepines during last 2 weeks before study)
Use of psychostimulants such as methylphenidate within 1 week of start of study
Diagnosed with medical conditions that affect cognition: Dementia, Alzheimer disease, Parkinson's disease, psychiatric disorders that affect cognition other than depression or anxiety complaints related to the disease
Active infection or other comorbidities that may contribute to REDOSE, February 2019 Page 7 of 53 fatigue or cognition change within 4 weeks of study entry
Clinical relevant anaemia
MoCa score \<20
Hypersensitivity to the active substance or to any of the excipients.
