A Phase 3 clinical trial, known as ProstACT GLOBAL, is underway in Australia and internationally, investigating a novel theranostic approach for advanced prostate cancer. Sponsored by Telix Pharmaceuticals, the study focuses on a radio antibody-drug conjugate (rADC) designed to target and treat prostate cancer cells with greater precision.
The ProstACT GLOBAL trial is a multinational, multicenter, prospective, randomised, controlled, open-label Phase 3 study targeting advanced progressive metastatic prostate cancer, which has not responded to other forms of treatment and has spread through the body. The trial drug is designed to bind to prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Once administered, the rADC selectively targets tumor cells, delivering radiation therapy directly to the cancer while minimizing damage to healthy tissues.
Dr. Aviral Singh, Principal Investigator at GenesisCare's Theranostics facility, emphasized the importance of the trial: "We are pleased to be the first location to advance this international trial and demonstrate GenesisCare’s commitment to searching for more ways to treat advanced prostate cancer in an exciting and emerging area of medicine." He further added, "Our aim is to support our patients while contributing to the growing body of research in the field of Theranostics and use of radiopharmaceuticals around the world. Clinical studies are crucial in understanding more about theranostics as a safe, targeted, and individualised treatment option."
The study's primary endpoints include overall survival and progression-free survival. Secondary endpoints focus on safety, quality of life, pharmacokinetics, biodistribution, and radiation dosimetry. These measures will provide comprehensive data on the rADC's efficacy, safety profile, and how it interacts with the body.
The ProstACT GLOBAL trial builds upon previous Phase 1 and Phase 2 studies that investigated the safety and potential benefits of this rADC. The current Phase 3 trial aims to provide more definitive evidence of its ability to improve overall survival and quality of life for patients with advanced prostate cancer.
