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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: Recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2025

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At a glance

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

Most Recent Events

  • 22 Jul 2025 According to a Telix Pharmaceuticals media release, patients in two of the three arms (abiraterone and enzalutamide as standard of care) have completed dosing. An interim readout of safety and dosimetry will follow the completion of patient dosing, monitoring and data analysis. The trial is entering into part 2 at existing ex-U.S. sites and additional regulatory approvals have been obtained to commence the trial in China, Canada and Japan.
  • 22 Jul 2025 According to a Telix Pharmaceuticals media release, 30 patients consented for part 1 and global expansion with regulatory approvals to expand the trial into China, Japan and Canada.
  • 03 Mar 2025 According to a Telix Pharmaceuticals media release, Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute in Salt Lake City, UT, will discuss the ProstACT Global Phase 3 trial of TLX591 (177Lu rosopatamab tetraxetan), in an investors webinar to be held on Tues Mar 11, 5.30pm

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