A Multinational, Multicenter, Prospective, Open-Label, Dosimetry and Safety Study of Lutetium (177Lu) rosopatamab tetraxetan in Combination with Standard of Care in Patients with PSMA Positive Metastatic Castration-Resistant Prostate Cancer after Androgen

This study aims to explore a possible new treatment for advanced prostate cancer that has spread to other parts of the body and tests positive for a specific protein called PSMA (prostate-specific membrane antigen). This treatment involves a special drug that seeks out cancer cells by recognizing PSMA on their surface. The drug combines an antibody— a molecule that can find and attach to specific targets on cancer cells—with a radioactive component. Once attached, it delivers radiation directly to the cancer cells to help destroy them. The drug being studied is called 177Lu-TLX591 (also known as 177Lu-DOTA-TLX591 or 177Lu-DOTA-rosopatamab tetraxetan). This is an investigational drug, meaning it hasn’t yet been approved by the U.S. Food and Drug Administration (FDA) and is still in the testing phase. In addition to this drug, the study also includes other medications often used in prostate cancer treatment, such as abiraterone, enzalutamide, and docetaxel. These treatments work in different ways to help fight cancer cells, and the study will look at how they might work together with 177Lu-TLX591.

Are you Eligible? (Inclusion Criteria)

• Be a male, at least 18 years old, with documented adenocarcinoma of the prostate defined by histological / pathological confirmation. 2. Participants must comply with the radiation protection rules (including hospital admissions and isolation) that are used by the treating institution in order to protect their contacts and the general public, especially if a female partner of the participant is or could be pregnant. 3. Have the capacity to understand the study and be able and willing to comply with all protocol requirements.