Overview

An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Soc, Versus SoC Alone, in Adult Male Patients With mHSPC

Status:
Recruiting

Trial end date:
2025-12-18

Target enrollment:

Participant gender:

Summary

The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC. In this study, the SoC is defined as a combination of Androgen Receptor Directed Therapy + Androgen Deprivation Therapy. Approximately 1126 patients will be randomized in this study.

Phase:

Phase 3

Details

Lead Sponsor:

Novartis Pharmaceuticals

Collaborators:

Alliance Foundation Trials, LLC.
RTOG Foundation, Inc.

Treatments:

177Lu-PSMA-617
Gallium 68 PSMA-11