Trial Profile

PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-Directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

Status: Active, no longer recruiting

Phase of Trial: Phase III

Latest Information Update: 15 Oct 2025

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At a glance

Drugs Lutetium (177Lu) vipivotide tetraxetan (Primary) ; Abiraterone; Androgen receptor antagonists; Enzalutamide; Gallium (68Ga) gozetotide
Indications Adenocarcinoma; Prostate cancer
Focus Registrational; Therapeutic Use
Acronyms PSMAfore
Sponsors Novartis; Novartis Pharmaceuticals

09 Oct 2025 Planned End Date changed from 29 Jan 2025 to 30 Sep 2026.
09 Oct 2025 Actual primary completion date changed from 3 Oct 2022 to 2 Oct 2022.
02 Jun 2025 According to a Novartis Media release, Pluvicto was recently granted US Food and Drug Administration (FDA) approval for earlier use in mCRPC, based on results from PSMAfore.

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