Phase 3 Study of Lutetium 177Lu Rosopatamab Tetraxetan with Standard Treatment versus Standard Treatment Alone in Men with PSMA-Positive Metastatic Castration-Resistant Prostate Cancer After Androgen Receptor Pathway Inhibitor Therapy

What this Trial Is About

Researchers are studying metastatic castration-resistant prostate cancer in men who have progressed after treatment with androgen receptor pathway inhibitors. The study aims to compare the length of time patients live without their cancer worsening on imaging when treated with 177Lu-TLX591 plus standard care versus standard care alone. This is a Phase 3 trial with a focus on both efficacy and safety of the new treatment in this patient group. Participants are divided into three parts a safety and dosimetry lead-in with 30 patients, a randomized treatment expansion with approximately 490 patients, and a long-term follow-up period lasting at least 5 years. In the randomized phase, patients receive either 177Lu-TLX591 plus standard of care, which may include enzalutamide, abiraterone, or docetaxel, or standard of care alone. The 177Lu-TLX591 is given as two doses about 14 days apart. Standard care treatments involve oral medications or chemotherapy as specified. During the study, participants will be regularly monitored through scans and other assessments to evaluate cancer progression and safety. Imaging includes PETCT or PETMRI scans to confirm PSMA positivity and detect disease spread. Researchers will track radiographic progression-free survival as the main outcome, along with overall survival and response rates. The long-term follow-up helps assess lasting effects and safety over several years. Participants are expected to adhere to study protocols and radiation safety precautions throughout their involvement.

The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)