The pharmaceutical company Novartis has published new data from a clinical trial (Phase III PSMAddition). According to the study, the radioligand therapy Pluvicto significantly delays disease progression in patients with metastatic hormone-sensitive prostate cancer (mHSPC) whose cells produce the PSMA protein (Prostate-Specific Membrane Antigen).<\/p>\n
This critical study, presented at the 2025 European Society for Medical Oncology (ESMO) Congress (Berlin), indicates that the approach to treating prostate cancer at an earlier stage may change. Specifically, combining Pluvicto with standard hormonal therapy resulted in a 28% reduction in the risk of disease progression or mortality compared to patients who received standard treatment alone.<\/p>\n
Prostate cancer is the second most common oncological disease in men worldwide. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) is the stage of the disease where hormone therapy is still effective. However, progression to metastatic Castration-Resistant Prostate Cancer (mCRPC) is common, which involves resistance to hormonal manipulation and is characterized by high risk and mortality rates.<\/p>\n
Pluvicto (which contains the radioactive substance lutetium(177<\/span><\/span><\/span><\/span><\/span><\/span><\/span><\/span>Lu<\/span><\/span><\/span><\/span><\/span><\/span>)) is a radionuclide therapy designed to specifically bind to the PSMA protein on the surface of tumor cells. Thanks to this mechanism, it selectively acts on the neoplastic cells. At this stage, Pluvicto is integrated into the standard hormonal regimen, which includes Androgen Deprivation Therapy (ADT) and Androgen Receptor Pathway Inhibitors (ARPI). This combination gains revolutionary importance in the therapeutic management of prostate cancer.<\/p>\n Key Findings of the Study:<\/strong><\/p>\n The PSMAddition study enrolled over 1,100 PSMA+ mHSPC subjects. Participants were randomly divided into two groups: 1) Pluvicto in addition to standard therapy (ADT+ARPI) and 2) Standard treatment only.<\/p>\n The study found that using Pluvicto along with hormonal treatment reduces the risk of cancer spread or patient death by 28%. It was also observed that Pluvicto potentially improves Overall Survival (OS), indicated by an initial trend of a 16% reduction in the risk of mortality (full confirmation of this data will occur later). Furthermore, patients showed better results in terms of treatment response, and the time it took for the disease to become hormone-resistant (mCRPC) significantly increased.<\/p>\n Safety:<\/strong><\/p>\n In this study, the side effects of Pluvicto were consistent with data from previous studies (PSMAfore, VISION). Grade 3 or higher adverse events occurred in approximately 51% of patients who received Pluvicto plus standard treatment, which is higher compared to the standard therapy-only group (43%).<\/p>\n The most common side effects were: xerostomia (dry mouth), fatigue, weakness, nausea, and anemia. Importantly, no events were recorded in the study that would affect urinary continence or sexual function. The latter is a crucial factor for the relatively younger mHSPC patients.<\/p>\n Scott Tagawa, MD, an oncologist from Weill Cornell Medicine, emphasized: Starting effective therapy early is vitally important in the treatment of metastatic prostate cancer. He stated that using Pluvicto along with hormonal treatment gives patients a long period of Progression-Free Survival and is accompanied by manageable side effects. Such clinical benefit, along with the Overall Survival (OS) rate, confirms the value of the therapy.<\/p>\n