{"groups":[{"description":"Participants were randomized to receive enzalutamide capsules 160 milligrams (mg)/day, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory prostate-specific antigen (PSA) evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"FG000","title":"Enzalutamide + Leuprolide"},{"description":"Participants were randomized to receive placebo capsules once daily, plus leuprolide 22.5 mg intramuscular or subcutaneous injection once every 12 weeks from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"FG001","title":"Placebo + Leuprolide"},{"description":"Participants were randomized to receive enzalutamide capsules 160 mg/day from Day 1. Study treatment continued uninterrupted in the absence of disease progression until the central laboratory PSA evaluation at Week 36. At week 37 study treatment was suspended for participants whose PSA values were undetectable at Week 36 and was reinitiated if subsequent PSA values increased to the threshold specified for reinitiation of study treatment. Participants with detectable PSA values at Week 36 continued treatment without suspension until permanent treatment discontinuation criteria were met.","id":"FG002","title":"Enzalutamide Monotherapy"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"66"},{"groupId":"FG002","numSubjects":"37"}],"type":"Centrally confirmed radiographic progression"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"20"},{"groupId":"FG002","numSubjects":"5"}],"type":"PSA progression notification from sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"36"},{"groupId":"FG002","numSubjects":"63"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"}],"type":"Development of castration resistance"},{"reasons":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"25"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"41"},{"groupId":"FG002","numSubjects":"26"}],"type":"PI decision/disease progression by local conventional scan/PSA, and other miscellaneous reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"207"},{"groupId":"FG001","numSubjects":"153"},{"groupId":"FG002","numSubjects":"197"}],"type":"Ongoing; still in treatment phase as of primary completion date (PCD) cutoff date 31 Jan 2023"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"1"}],"type":"Participants did not receive treatment."}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"355"},{"groupId":"FG001","numSubjects":"358"},{"groupId":"FG002","numSubjects":"355"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"353"},{"groupId":"FG001","numSubjects":"354"},{"groupId":"FG002","numSubjects":"354"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"355"},{"groupId":"FG001","numSubjects":"358"},{"groupId":"FG002","numSubjects":"355"}],"type":"NOT COMPLETED"}],"title":"Study Treatment Phase"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"67"},{"groupId":"FG001","numSubjects":"104"},{"groupId":"FG002","numSubjects":"62"}],"type":"Ongoing; participants still in long-time follow-up phase as of the PCD cutoff date (31 January 2023)"},{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"12"}],"type":"PI decision, site closure and other miscellaneous reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"36"},{"groupId":"FG002","numSubjects":"38"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"4"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"54"},{"groupId":"FG002","numSubjects":"42"}],"type":"Death"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"205"},{"groupId":"FG002","numSubjects":"158"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"148"},{"groupId":"FG001","numSubjects":"205"},{"groupId":"FG002","numSubjects":"158"}],"type":"NOT COMPLETED"}],"title":"Long-Term Follow-Up Phase"}],"preAssignmentDetails":"A total of 1068 participants were enrolled and randomized to the 3 treatment groups. There were 2 participants in the enzalutamide plus leuprolide group, 4 participants in the placebo plus leuprolide group, and 1 participant in the enzalutamide monotherapy group who did not receive any study intervention."}