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: 30 Jul 2026
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
- 21 Jul 2026 According to a Telix Pharmaceuticals media release, Part 2 continues to enroll strongly in regions where recruitment is open including Australia, New Zealand, Canada, Turkiye, the United Kingdom, Singapore and South Korea and has also received regulatory approval to commence in China.
- 21 Jul 2026 According to a Telix Pharmaceuticals media release, the FDA has confirmed that safety data from Part 1 of the study is sufficient to enable progression of Part 2 in the U.S. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. Initiation of Part 2 in the U.S. remains subject to the FDA's review of an Investigational New Drug (IND) amendment.
- 20 Feb 2026 Status changed from recruiting to discontinued.