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)
Latest Information Update: 28 Aug 2025
At a glance
- Drugs Lutetium (177Lu) vipivotide tetraxetan (Primary) ; Piflufolastat F18 (Primary)
- Indications Prostate cancer
- Focus Registrational; Therapeutic Use
- Acronyms PSMA-DC
- Sponsors Novartis Pharmaceuticals
Most Recent Events
- 21 Aug 2025 Planned End Date changed from 9 Jul 2030 to 6 Nov 2029.
- 21 Aug 2025 Planned primary completion date changed from 21 Dec 2027 to 31 Mar 2026.
- 16 Jun 2025 Planned number of patients changed from 450 to 458.