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A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase 3 Study With Best Standard of Care With and Without 177Lu-DOTA-rosopatamab for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug

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Trial Profile

A Multinational, Multicenter, Prospective, Randomized, Controlled, Open Label Phase 3 Study With Best Standard of Care With and Without 177Lu-DOTA-rosopatamab for Patients With PSMA Expressing Metastatic Castration-resistant Prostate Cancer Progressing Despite Prior Treatment With a Novel Androgen Axis Drug

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2026

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At a glance

  • Drugs Lutetium 177 DOTA rosopatamab (Primary) ; Abiraterone; Antineoplastics; Docetaxel; Enzalutamide; Prednisolone; Prednisone
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PROSTACT; ProstACT GLOBAL
  • Sponsors Telix Pharmaceuticals

Most Recent Events

  • 20 Feb 2026 Status changed from recruiting to discontinued.
  • 19 Feb 2026 According to a Telix Pharmaceuticals media release, Completed target enrollment of 30 patients for Part 1 of the ProstACT Global10 Phase 3 study in metastatic castration resistant prostate cancer (mCRPC). First patients treated in Part 2 (randomized expansion)
  • 29 Jan 2026 According to a Telix Pharmaceuticals media release, the trial is now open for enrollment in Japan.

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