Phase 3 trial: 177Lu-DOTA-rosopatamab (TLX591) for patients with PSMA expressing metastatic castration-resistant prostate cancer
Doctors in Perth, Australia have taken the lead in a global Phase 3 clinical trial called ProstACT GLOBAL, focusing on a new radiopharmaceutical treatment for advanced prostate cancer. This trial, sponsored by Telix Pharmaceuticals, is underway at GenesisCare’s Theranostics facility located at St John of God Murdoch Hospital.
At the heart of this research is 177Lu-DOTA-rosopatamab (TLX591), a radio antibody-drug conjugate (rADC) designed to target prostate-specific membrane antigen (PSMA). PSMA is a protein found on the surface of prostate cancer cells. The rADC works by attaching to PSMA and delivering targeted radiation therapy directly to the tumor cells. This precise approach aims to minimize damage to healthy surrounding tissues.
ProstACT GLOBAL is a multinational, multicenter, randomized, controlled, and open-label Phase 3 study. This rigorous design ensures that the results are reliable and applicable to a wider patient population. The trial specifically focuses on men with advanced, progressive metastatic prostate cancer who have not responded to other forms of treatment.
Key Objectives of the ProstACT GLOBAL Trial:
● Efficacy: Assessing the impact of 177Lu-DOTA-rosopatamab on overall survival and progression-free survival.
● Safety: Monitoring and evaluating potential adverse effects associated with the treatment.
● Quality of Life: Measuring the impact of the treatment on patients’ quality of life.
● Pharmacokinetics, Biodistribution, and Radiation Dosimetry: Studying the drug’s behavior within the body, including its absorption, distribution, metabolism, and excretion, as well as its uptake in tumors and organs.
This Phase 3 trial builds upon the promising findings of previous Phase 1 and Phase 2 studies, which have indicated the safety and potential benefits of this rADC in terms of survival and quality of life for prostate cancer patients.
Dr. Aviral Singh, the clinical head of theranostics and nuclear medicine at GenesisCare and a principal investigator on the trial, emphasizes the significance of the study: “Clinical studies are crucial in understanding more about theranostics as a safe, targeted, and individualized treatment option”. The results of ProstACT GLOBAL hold the potential to advance the field of theranostics and offer a new hope for men with advanced prostate cancer.