{"groups":[{"description":"Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan\n\nrhPSMA-7.3 (18F) Injection: Radioligand for PET CT scanning\n\nPositron Emission Tomography scan: imaging test with radioligand","id":"FG000","title":"Patients"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Adverse Event"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Opted for EBRT"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Opted SBRT"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"Patient decided to have focal ablation and not surgery"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Physician Decision"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"RP Delayed"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Sponsor Decision: Outdated FU Timeline"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Subject declined for financial reasons"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"The subject declined any biopsy or surgery due to COVID-19 pandemic"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"The subject declined for any biopsy or other imaging"},{"reasons":[{"groupId":"FG000","numSubjects":"2"}],"type":"The subject opted for other treatment option"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"The subject opted for other treatment options"},{"reasons":[{"groupId":"FG000","numSubjects":"3"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"1"}],"type":"Reason not specified"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"356"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"336"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"20"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Baseline safety evaluations performed at screening (Visit 1) comprised vital signs, focused physical examination and recording of any adverse events (AEs) from the time of informed consent.","recruitmentDetails":"This study was from 02 Mar 20 (first patient, screening visit) and 18 Feb 22 (database lock), with the last patient, last visit on 21 Jun 21. It was conducted at 34 activated study sites (31 recruited) in 4 countries. Of the 372 patients screened, 356 patients met all the study eligibility criteria. 16 patients were screen failures so not included"}