Clinical trials of a new generation of alpha decay nuclide [225Ac] for the treatment of metastatic castration-resistant prostate cancer were officially launched in our hospital
On April 21, "An open, international, multi-center, randomized, phase II/III study (trial code: CAAA817A12201) comparing AAA817 with standard treatment in adult participants with PSMA-positive metastatic castration-resistant prostate cancer that progressed during or after [177Lu]Lu-PSMA targeted therapy (trial code: CAAA817A12201)", undertaken by Peking University Cancer Hospital as the team leader, was officially launched. This project is one of the first batch of optimized innovative clinical trial pilot projects of the Beijing Municipal Food and Drug Administration. Professor Song Yuqin, Vice President of the Hospital, Director Jiang Min of the Institutional Office, Professor Yang Zhi of the Department of Nuclear Medicine, the leading Chinese investigators, Professor Du Peng of the Department of Urology, and the core research team, senior representatives of the sponsor including the head of R&D oncology, medical director, clinical operations director and other core management and project members, as well as SMO representatives attended the kick-off meeting to discuss the program implementation standards and patient benefit paths. Sharing professional insights from drug research and development background, early data, clinical layout and other dimensions marks the launch of this innovative therapy in China and fills the gap in clinical demand.
Prostate cancer is one of the most common malignant tumors in men, although a variety of drugs have emerged for treatment at different stages. However, castration-resistant prostate cancer is still a difficult problem in the clinical treatment field. Radioligand therapy (RLT) targeting prostate-specific membrane antigen (PSMA), represented by ¹⁷⁷Lu, has demonstrated excellent therapeutic efficacy and safety in multiple clinical trials. However, the low radiation energy of ¹⁷⁷Lu as a beta-decay nuclide may lead to clinical challenges such as insufficient patient response rates and higher risk of recurrence and metastasis. In comparison, the alpha decay nuclide ²²⁵Ac has higher radiation energy and requires a lower injection dose, which brings new treatment hope to end-line prostate cancer patients.
The official launch of this trial not only demonstrates the leadership and innovative strength of Peking University Cancer Hospital in the field of international cancer clinical research, but also marks a key step in China's precision diagnosis and treatment of prostate cancer. In the future, with the further development of trials, it is expected that new α-decay nuclide therapy represented by ²²⁵Ac can break through the bottleneck of traditional treatment and bring more significant survival benefits and treatment options to patients with PSMA-positive metastatic castration-resistant prostate cancer around the world.