{"groups":[{"description":"Participants received 160 mg of enzalutamide orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide during double-blind treatment period and provided informed consent to take part in open-label period continued to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"FG000","title":"Enzalutamide + Androgen Deprivation Therapy (ADT)"},{"description":"Participants received enzalutamide matching placebo orally once daily during double-blind treatment period until radiographic progression was documented or until the participants started an investigational agent or new therapy for treatment of prostate cancer or until any other discontinuation criterion was met. Eligible participants who received enzalutamide matching placebo during double-blind treatment period and provided informed consent to take part in open-label period switched to receive 160 mg enzalutamide orally once daily in open-label period until disease progression, unacceptable toxicity or any other discontinuation criteria were met. ADT (either bilateral orchiectomy or LHRH agonist/antagonist) was maintained during study treatment as per standard of care and provided by the site's pharmacy stock.","id":"FG001","title":"Placebo + Androgen Deprivation Therapy (ADT)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"117"},{"groupId":"FG001","numSubjects":"197"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"15"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"6"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"71"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"30"},{"groupId":"FG001","numSubjects":"99"}],"type":"Miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"370"},{"groupId":"FG001","numSubjects":"182"}],"type":"Continued in OLE"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}],"type":"Discontinued by Sponsor"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"}],"type":"Randomized, Not Treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"574"},{"groupId":"FG001","numSubjects":"576"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"572"},{"groupId":"FG001","numSubjects":"574"}],"type":"Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"574"},{"groupId":"FG001","numSubjects":"576"}],"type":"NOT COMPLETED"}],"title":"Double Blind Period (up to 35 Months)"},{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"73"},{"groupId":"FG001","numSubjects":"26"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"3"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"22"},{"groupId":"FG001","numSubjects":"10"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"13"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"241"},{"groupId":"FG001","numSubjects":"125"}],"type":"Miscellaneous"},{"reasons":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"5"}],"type":"Discontinued by Sponsor"}],"milestones":[{"achievements":[{"comment":"Eligible participants who provided consent took part in open-label period","groupId":"FG000","numSubjects":"370"},{"comment":"Eligible participants who provided consent took part in open-label period","groupId":"FG001","numSubjects":"182"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"370"},{"groupId":"FG001","numSubjects":"182"}],"type":"NOT COMPLETED"}],"title":"Open-Label Extension (Approx. 66 Months)"}],"preAssignmentDetails":"The randomization was stratified by volume of disease (low vs high) and prior docetaxel therapy for prostate cancer (no prior docetaxel, 1 to 5 cycles, 6 cycles).","recruitmentDetails":"Participants with metastatic hormone sensitive prostate cancer (mHSPC) were enrolled in 204 study sites worldwide."}