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
Telix Pharmaceuticals (Innovations) Pty Limited
Summary
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
Description
The primary objective of the study is to compare radiographic progression-free survival (rPFS) in participants who receive 177Lu-TLX591 with SOC to rPFS in participants who receive SOC only. This study consists of three Parts: * Part 1: Safety and Dosimetry Lead-in, * Part 2: Randomized Treatment Expansion, and * Part 3: Long-term Follow-up The study will commence with a 30-patient safety and dosimetry lead-in (Part 1) and proceed to a randomization treatment expansion in approximately 490 patients (Part 2). Patients in Part 2 will be randomized in a 2:1 ratio to receive either 177Lu-TLX59…