{"groups":[{"description":"Patients randomized to receive the investigational product received 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) might be used","id":"FG000","title":"Main Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)"},{"description":"Patients randomized to this arm received best supportive/best standard of care (BS/BSOC) as determined by the investigator","id":"FG001","title":"Main Study: Best Supportive/Best Standard of Care (BS/BSOC) Alone"},{"description":"non-randomized cohort (AAA617+ BS/BSOC) at sites in Germany to provide a more complete assessment of the safety aspects of AAA617. Patients were treated and followed up similarly to the AAA617+BSC/BSOC (investigational arm) patients in the main study","id":"FG002","title":"Sub Study: 177Lu-PSMA-617 Plus Best Supportive/Best Standard of Care (BS/BSOC)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"457"},{"groupId":"FG001","numSubjects":"201"},{"groupId":"FG002","numSubjects":"21"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"40"},{"groupId":"FG001","numSubjects":"63"},{"groupId":"FG002","numSubjects":"3"}],"type":"Withdrew consent"},{"reasons":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"2"}],"type":"Other protocol pre-specified reasons for discontinuation"},{"reasons":[{"groupId":"FG000","numSubjects":"8"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"}],"type":"Patient non-compliance"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"551"},{"groupId":"FG001","numSubjects":"280"},{"groupId":"FG002","numSubjects":"30"}],"comment":"All randomized patients were included in the Full Analysis Set (FAS). Patients were included in the treatment arm to which they were randomized regardless of actual treatment received.","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"529"},{"groupId":"FG001","numSubjects":"205"},{"groupId":"FG002","numSubjects":"30"}],"comment":"The subset of patients in the Full Analysis Set (FAS) who received at least one dose of randomized treatment.","type":"FAS Safety Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"385"},{"groupId":"FG001","numSubjects":"196"},{"groupId":"FG002","numSubjects":"0"}],"comment":"All patients randomized on or after 05-Mar-2019. Patients were included in the treatment arm to which they were randomized regardless of actual treatment received.","type":"Progression-Free Survival (PFS) Full Analysis Set (PFS-FAS)"},{"achievements":[{"groupId":"FG000","numSubjects":"319"},{"groupId":"FG001","numSubjects":"120"},{"groupId":"FG002","numSubjects":"0"}],"comment":"The subset of patients in the PFS-FAS with evaluable disease by RECIST at baseline. Patients were included in the treatment arm to which they were randomized.","type":"Response Evaluable Analysis Set"},{"achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"4"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"523"},{"groupId":"FG001","numSubjects":"274"},{"groupId":"FG002","numSubjects":"26"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"recruitmentDetails":"The study was conducted in 86 sites across 9 countries. Belgium (3); Canada (7); Denmark (3); France (6); Netherlands (4); Sweden (5); UK (9); US (45); Germany (4, for the sub-study only)."}