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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

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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: 17 Sep 2026

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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

Most Recent Events

  • 07 Aug 2026 Planned End Date changed from 30 Sep 2026 to 10 Sep 2026.
  • 24 Apr 2026 According to a European Medicines Agency media release, the The application for a new use of Pluvicto (lutetium (177Lu) vipivotide tetraxetan), a medicine to treat cancer of the prostate, to treat adults with PSMA-positive mCRPC who have no or mild symptoms, after their cancer has worsened despite treatment with a hormone blocking medicine, was withdrawn.
  • 09 Oct 2025 The protocol has been amended to change in study time frame for its primary endpoint.

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