|
Baseline
|
1 month
|
2 months
|
3 months
|
Every 1 month
|
Every 3 months
|
Discontinuation of therapy
|
---|
Informed consent
| ○ | | | | | | |
Medical history
| ○ | | | | | | |
Confirmation of eligibility criteria
| ○ | | | | | | |
Randomization
| ○ | | | | | | |
Serum testosterone
| ○ | | | | | | |
FACT-P
| ○ |
–
|
–
| ○ |
–
| ○ | ○ |
PSAa
| ○ | ○ | ○ | ○ | ○ | ○ | ○ |
Biochemical examinationa
| ○ | ○ | ○ | ○ | ○ | ○ | ○ |
CT, bone scintigraphy
| ○ |
When progressive disease is suspectedb
| ○ |
Safety
| ○ | ○ | ○ | ○ | ○ | ○ | ○ |
Further therapy
|
–
|
–
|
–
|
Best standard care
|
- aAfter the discontinuation of enzalutamide or flutamide, PSA and biochemical examination will be continued until September 2018
- bWhen progressive disease is suspected, CT and bone scintigraphy will be performed to confirm radiographic disease progression