{"groups":[{"description":"All patients who were scheduled to receive the rhPSMA-7.3 (18F) injection having met the inclusion/exclusion criteria or who received the rhPSMA-7.3 (18F) injection.","id":"FG000","title":"Single Arm"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Biopsy ordered but area too small to biopsy"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Biopsy ordered but not done"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"It was previously confirmed"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Patient cancelled scheduled scans"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"PSMA PET/CT scan show disease within previously Bx area"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Subject refused confirmatory imaging"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Too small to biopsy"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"391"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"378"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"13"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Baseline safety evaluations performed at screening (Visit 1) comprised vital signs and recording of any adverse events (AEs) from the time of informed consent. Conventional images collected within 90 days of rhPSMA7.3 (18F) PET, followed by biopsy within 60 days post-PET scan or confirmatory imaging within 90 days post-PET scan","recruitmentDetails":"This study was conducted from 04 May 20 (first patient, screening visit) and 12 Oct 21 (database lock), with last patient, last visit on 28 Apr 21. It was conducted at 28 activated study sites (27 recruited) in 3 countries. Of the 420 patients screened, 391 patients met all the study eligibility criteria"}