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: 26 Nov 2025
Price :
$35
*
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
- 14 Oct 2025 According to a Telix Pharmaceuticals media release, Part 1 preliminary readout of safety profile and dosimetry will be done after completion of patient monitoring and data analysis.
- 14 Oct 2025 According to a Telix Pharmaceuticals media release, Telix has closed enrollment into Part 1 of ProstACT Global. Part 2 (randomized treatment expansion) has opened for enrollment in Australia, New Zealand and Canada, and with further sites to be opened in China, Singapore, Turkiye and Japan, where the study has regulatory approval.
- 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.