# An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.

Source: https://nuclide.cc/trials/nct05939414/  
Nuclide record `nct05939414` (Trial). Data CC BY-NC 4.0, attribute "Data from Nuclide (nuclide.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: 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
- Enrolled: 450

## Sources

- ClinicalTrials.gov NCT05939414: https://clinicaltrials.gov/study/NCT05939414

## Connected records

- isotopes: [Fluorine-18](https://nuclide.cc/isotopes/f-18/), [Gallium-68](https://nuclide.cc/isotopes/ga-68/), [Lutetium-177](https://nuclide.cc/isotopes/lu-177/)
- indications: [Prostate cancer](https://nuclide.cc/indications/prostate/)
- drugs: [FAP-2286 (177Lu / 68Ga)](https://nuclide.cc/drugs/fap-2286/)
- companies: [Novartis](https://nuclide.cc/companies/novartis/)

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