A Multinational, Multicenter, Prospective, Randomized, Controlled, Open-Label, Phase 3 Study of Lutetium (177Lu) Rosopatamab Tetraxetan in Combination With Standard of Care Versus Standard of Care Alone in Patients With PSMA Positive Metastatic Castration-Resistant Prostate Cancer Previously After Androgen Receptor Pathway Inhibitor Treatment

NCT06520345 Phase 3 RECRUITING

The purpose of this study is to evaluate the efficacy and safety of 177Lu-TLX591 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with Androgen Receptor Pathway Inhibitor Treatment

Details

Lead sponsor	Telix Pharmaceuticals (Innovations) Pty Limited
Phase	Phase 3
Status	RECRUITING
Enrolment	520
Start date	2024-07-26
Completion	2030-12

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

• 177Lu-TLX591
• Enzalutamide
• Abiraterone
• Docetaxel

Primary outcomes

• Radiographic Progression-free Survival — 337days
  time from randomization to disease progression confirmed by central independent radiology review according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria (which incorporates Response Evaluation Criteria in Solid Tumors, RECIST 1.1, for soft tissue lesions), or death (whichever occurs first)

Countries

United States, Australia, Canada, New Zealand, Turkey (Türkiye), United Kingdom