{"entity":{"id":"nct05939414","kind":"trial","name":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.","aka":[],"tldr":"A phase 3 trial of FAP-2286 in prostate cancer, run by Novartis Pharmaceuticals, now recruiting.","summary":"An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC. is a phase 3 interventional study registered as NCT05939414 by Novartis Pharmaceuticals, with 450 participants planned, started 2024-03-12 and due to reach its primary completion in 2028-04-25. Interventions recorded: AAA617, piflufolastat (18F), gallium (68Ga) gozetotide (25μg). Conditions listed: Oligometastatic Prostate Cancer (OMPC). No results are recorded here; the registry entry is the source.","status":"recruiting","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT05939414","url":"https://clinicaltrials.gov/study/NCT05939414"}],"tags":["ctgov-ingest"],"related":[],"cancers":["prostate"],"sections":[],"technologies":["fapi-pet","radioligand-therapy"],"targets":[],"drugs":["fap-2286"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05939414","phase":"3","setting":"An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)","sponsor":"Novartis Pharmaceuticals","participation":[{"nct":"NCT05939414","source":"https://clinicaltrials.gov/study/NCT05939414","fetchedAt":"2026-10-07T16:54:02.117Z","studySha256":"71d72d4309d2e88c9a9084d436cf4ea14a3844bfffdec2d8f89f6c3919603dd0","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-22","leadSponsor":"Novartis Pharmaceuticals","collaboratorCount":0,"minimumAge":"18 Years","maximumAge":"100 Years","sex":"MALE","healthyVolunteers":false,"hasEligibility":true,"enrolment":450,"enrolmentType":"ESTIMATED","siteCount":144,"recruitingSiteCount":140,"countries":["Argentina","Australia","Austria","Belgium","Brazil","Canada","China","Colombia","Czechia","France","Germany","Greece","Hungary","Israel","Italy","Japan","Malaysia","Mexico","Netherlands","Puerto Rico","Singapore","Slovakia","Spain","Switzerland","Taiwan","United Kingdom","United States"]}],"started":"2024-03-12","startedType":"actual","enrolled":450,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05939414/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"fapi-pet","kind":"technology","name":"FAPI PET","route":"/technologies/fapi-pet/"},{"id":"radioligand-therapy","kind":"technology","name":"Radioligand therapy (beta emitters)","route":"/technologies/radioligand-therapy/"}],"drug":[{"id":"fap-2286","kind":"drug","name":"FAP-2286 (177Lu / 68Ga)","route":"/drugs/fap-2286/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}