drugset / Trial / NCT05939414

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

NCT05939414 ↗

Phase 3 Recruiting 450 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of lutetium (177Lu) vipivotide tetraxetan (AAA617) in participants with oligometastatic prostate cancer (OMPC) progressing after definitive therapy to their primary tumor. The data generated from this study will provide evidence for the treatment of AAA617 in early-stage prostate cancer patients to control recurrent tumor from progressing to fatal metastatic disease while preserving quality of life by delaying treatment with androgen deprivation therapy (ADT).

Timeline

Start
2024-03-12
Primary completion
2028-04-25
Completion
2031-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject AAA617 Other / unclassified 7400 mbq Other
Background 18F-DCFPyL Diagnostic / imaging agent — —
Background 68Ga-PSMA-11 Diagnostic / imaging agent 25 ug —