{"groups":[{"description":"Participants received 160 milligrams (mg) of enzalutamide orally once a day during double blind period until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 29.4 months). Eligible participants who received enzalutamide during double blind and who provided consent to take part in open-label period continued to receive 160 mg of enzalutamide in open-label period orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 54.3 months).","id":"FG000","title":"Enzalutamide"},{"description":"Participants received enzalutamide matching placebo orally once a day during double-blind period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 18.6 months).","id":"FG001","title":"Placebo"},{"description":"Eligible participants who received enzalutamide matching placebo during Double Blind period and who provided consent to take part in Open label period, received 160 mg of enzalutamide orally once a day during open-label period until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer (up to 53.8 months).","id":"FG002","title":"Placebo Patients Crossover to Enzalutamide 160 mg"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"0"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"66"},{"groupId":"FG002","numSubjects":"0"}],"type":"Miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"54"},{"groupId":"FG002","numSubjects":"0"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"51"},{"groupId":"FG002","numSubjects":"0"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"0"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"202"},{"groupId":"FG001","numSubjects":"193"},{"groupId":"FG002","numSubjects":"0"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"202"},{"groupId":"FG001","numSubjects":"193"},{"groupId":"FG002","numSubjects":"0"}],"type":"Treated/Received Study Drug"},{"achievements":[{"groupId":"FG000","numSubjects":"84"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"118"},{"groupId":"FG001","numSubjects":"192"},{"groupId":"FG002","numSubjects":"0"}],"type":"NOT COMPLETED"}],"title":"Double-blind Period (up to 29.4 Months)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"16"}],"type":"Miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"10"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Protocol Deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"12"}],"type":"Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"5"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"6"}],"type":"Adverse Event"}],"milestones":[{"achievements":[{"comment":"Eligible participants who provided consent took part in open-label period.","groupId":"FG000","numSubjects":"85"},{"comment":"Eligible participants who provided consent took part in open-label period.","groupId":"FG001","numSubjects":"0"},{"comment":"Eligible participants who provided consent took part in open-label period.","groupId":"FG002","numSubjects":"51"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"85"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"51"}],"type":"NOT COMPLETED"}],"title":"Open-label Period (up to 54.3 Months)"}],"preAssignmentDetails":"Participants who met inclusion criteria and none of the exclusion criteria were enrolled in the study.","recruitmentDetails":"The study population consisted of men with asymptomatic or mildly symptomatic progressive metastatic prostate cancer, who had failed androgen deprivation therapy, and have not been treated with cytotoxic chemotherapy. Participants from 46 study sites in 4 countries (China, Korea, Taiwan and Hong Kong) were randomized for the study."}