| 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 |
Nature et Objective
This is a multinational, multicenter, prospective, randomized, controlled, open-label Phase 3 study designed to investigate and confirm the benefits and risks associated with 177Lu-TLX591 administered together with SOC compared to SOC alone, in participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) who have progressed after their first treatment with an ARPI (specifically abiraterone, apalutamide, darolutamide or enzalutamide) or docetaxel administered during either the metastatic castrate-sensitive prostate cancer (mCSPC), non-metastatic castration resistant prostate cancer (nmCRPC) or first-line metastatic castrate-resistant prostate cancer (mCRPC) treatment setting. The purpose of this study is to evaluate the efficacy and safety of 177Lu‑TLX591 in patients with metastatic castration‑resistant prostate cancer (mCRPC) who have progressed following treatment with an androgen receptor pathway inhibitor (ARPI). 177Lu‑TLX591 is a PSMA‑targeted radiopharmaceutical designed to deliver radiation directly to prostate cancer cells expressing PSMA, potentially improving tumor control while limiting exposure to surrounding tissues