Telix Pharmaceuticals has dosed the first patient in its pivotal Phase III registration study of TLX591-Px (Illuccix, Kit for the preparation of 68Ga-PSMA-11) aimed at prostate cancer imaging in Japanese patients.
The dosing took place at Shonan Kamakura General Hospital in Kamakura, Japan. The trial aims to further evaluate detection safety and efficacy in this population.
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The Illuccix Japan study is an open-label, multi-centre, prospective Phase III trial assessing 68Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) in biochemically recurrent prostate cancer patients after prior radical prostatectomy.
Up to 105 Japanese men will be enrolled at 11 sites, with data aimed at supporting a future marketing authorisation submission for TLX591-Px in the country.
The primary objective is to compare 68Ga-PSMA-11 PET/CT sensitivity with conventional imaging methods, including CT and bone scintigraphy, in detecting metastatic lesions.
Secondary goals involve assessing the diagnostic performance for both distant and local lesions, evaluating tolerability and safety, and determining how this imaging approach may influence clinical management decisions.
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By GlobalDataTelix Group chief medical officer Dr David Cade said: “PSMA-PET imaging has fundamentally changed how we detect and manage prostate cancer, providing greater accuracy and confidence in treatment planning compared with conventional imaging. Yet, access remains limited in much of Japan, where 68Ga-PSMA-11 is not fully validated in the local clinical setting or across all stages of the disease.
“This milestone, together with Telix’s existing compassionate use supply to address unmet patient need, brings us significantly closer to improving access to gallium-based PSMA-PET and improving outcomes for men living with prostate cancer in Japan.”
TLX591-Px (Illuccix) is the company’s first-generation PSMA-PET imaging agent and received approvals in multiple markets globally, but remains investigational only in Japan.
In June 2025, Telix introduced a PET radiochemistry solution, AlFluor, based on ¹⁸F-aluminium fluoride (AlF).
