Enzalutamide versus flutamide for castration-resistant prostate cancer after combined androgen blockade therapy with bicalutamide: study protocol for a multicenter randomized phase II trial (the OCUU-CRPC study)

Table 1 Follow-up schedule of examination

	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	○	–	–	○	–	○	○
PSA^a	○	○	○	○	○	○	○
Biochemical examination^a	○	○	○	○	○	○	○
CT, bone scintigraphy	○	When progressive disease is suspected^b					○
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

ISSN: 1471-2407