{"groups":[{"description":"Participants received 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles. Best supportive care, including ADT could be used.","id":"FG000","title":"177Lu-PSMA-617 (AAA617)"},{"description":"For participants randomized to the ARDT arm, the change of ARDT treatment was administered per the physician's orders. Best supportive care, including ADT could be used.","id":"FG001","title":"Androgen Receptor-directed Therapy (ARDT)"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"5"}],"type":"Subject decision"},{"reasons":[{"groupId":"FG000","numSubjects":"12"},{"groupId":"FG001","numSubjects":"12"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"32"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"54"},{"groupId":"FG001","numSubjects":"173"}],"type":"Progressive disease"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"type":"Treated but excluded from FAS because of protocol deviation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"9"}],"type":"Treatment ongoing at the data cut-off date of 1-Jan-2025"},{"reasons":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participants not treated"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"235"},{"groupId":"FG001","numSubjects":"234"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"228"},{"groupId":"FG001","numSubjects":"232"}],"type":"Participants Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"234"},{"groupId":"FG001","numSubjects":"234"}],"comment":"The Full Analysis Set (FAS) comprised all participants to whom study treatment was assigned by randomization.","type":"Full Analysis Set (FAS)"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Excluded from Full Analysis Set \\& Safety Set due to protocol deviation (informed consent not obtained per due process)","type":"Excluded From FAS"},{"achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"2"}],"type":"Participants Not Treated"},{"achievements":[{"groupId":"FG000","numSubjects":"96"},{"groupId":"FG001","numSubjects":"223"}],"type":"Discontinued Study Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"227"},{"groupId":"FG001","numSubjects":"232"}],"comment":"The Safety Set included all participants who received at least one dose of study treatment (i.e., at least one dose of (AAA617 or ARPIs) during the randomized part of the protocol.","type":"Safety Set"},{"achievements":[{"groupId":"FG000","numSubjects":"131"},{"groupId":"FG001","numSubjects":"0"}],"comment":"Completed = Completed treatment","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"104"},{"groupId":"FG001","numSubjects":"234"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"During screening, all participants underwent imaging with the investigational product gallium (68Ga) gozetotide for the purpose of determining eligibility.","recruitmentDetails":"Informed consent was obtained from all eligible participants who were randomized via Interactive Response Technology (IRT) to one of the arms in a 1:1 ratio: 177Lu-PSMA-617 or Androgen receptor-directed therapy (ARDT)."}