The Study of 177Lu-TLX591 Plus SOC Versus SOC Alone in Patients With mCRPC (ProstACT Global)
PROSTACT GLOBAL EXPLAINED
TLX591 comprises a radioactive isotope, Lutetium-177, attached to an antibody called rosopatamab.
Rosopatamab targets prostate-specific membrane antigen (PSMA), a protein expressed on the surface of prostate cancer cells, which is low or absent on most normal healthy cells.
When you have prostate cancer, you may have a lot more PSMA than normal, particularly in the prostate cancer cells and other areas where the cancer may have spread (called metastatic lesions). This can make PSMA a good target for treating advanced prostate cancer.
Metastatic castration-resistant prostate cancer (mCRPC) is a type of prostate cancer that has spread to other parts of your body and is no longer responding to hormone treatment that lowers testosterone levels.
If you have mCRPC, you may also be PSMA-positive. A PSMA PET scan can help find out.
A PSMA PET scan is an advanced imaging test used to detect PSMA-positive cells in the body. These cells are commonly found in prostate cancer. This scan helps your doctor see if your cancer expresses PSMA, which can guide treatment decisions, including whether targeted therapies may be suitable.
Why Participate in this study?
This global Phase 3 study is designed to investigate and confirm the benefits and risks associated with TLX591 administered together with standard of care (SoC), as compared to the best SoC alone. The study is being conducted in patients with metastatic castrate-resistant prostate cancer (mCRPC) that expresses PSMA, and has progressed despite prior treatment with hormone therapy.
WHAT WILL HAPPEN IN THE STUDY?
This study will be completed in 2 parts. Participants in Part 1 of the study, which has now been completed, received TLX591 + SOC. Participants in Part 2 of the study will be assigned randomly (by chance not choice) to receive either TLX591 + SOC, or SoC alone.
TLX591 + SoC (includes Abiraterone + Prednisone, Enzalutamide or Docetaxel. Your doctor will decide which SoC is best for you)
or
SoC alone
© 2024 Telix Pharmaceuticals Limited
ClinicalTrials.gov ID: NCT06520345
The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
TLX591 is for investigational use only and has not received a marketing authorisation in any country worldwide.
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