{"groups":[{"description":"Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.","id":"FG000","title":"Placebo + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \\[GnRHa\\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.","id":"FG001","title":"Apalutamide + ADT"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"527"},{"groupId":"FG001","numSubjects":"525"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"527"},{"groupId":"FG001","numSubjects":"524"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"NOT COMPLETED"}],"title":"Randomized"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"62"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"13"},{"groupId":"FG001","numSubjects":"11"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"6"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"36"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"245"},{"groupId":"FG001","numSubjects":"138"}],"type":"Other: Progressive Disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Other"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"267"}],"type":"Ongoing"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"527"},{"groupId":"FG001","numSubjects":"524"}],"type":"STARTED"},{"achievements":[{"comment":"Participants crossed over from placebo to apalutamide after positive results at interim analysis.","groupId":"FG000","numSubjects":"208"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"319"},{"groupId":"FG001","numSubjects":"524"}],"type":"NOT COMPLETED"}],"title":"Treated"}],"preAssignmentDetails":"Per protocol, 208 participants randomized to receive placebo+ADT were switched over to receive apalutamide+ADT after interim analysis and unblinding. Randomized treatment disposition has been reported in participant flow. Response/progression that occurred during a non-randomized switch-over to apalutamide+ADT were not counted towards efficacy outcome measures."}