Full Press Release Details
Melbourne (Australia) and Tokyo (Japan) | July 17, 2026
Telix today announced completion of patient enrollment in the pivotal Phase 3 registration study of TLX591-Px (Illuccix®, Kit for the preparation of 68 Ga-PSMA-11 [1] ) for prostate cancer imaging in Japanese patients.
Illuccix Japan [2] is a Phase 3 prospective, open-label, multicenter study designed to evaluate the detection efficacy and safety profile of 68 Ga-PSMA-11 PET/CT [3] in Japanese patients with biochemically recurrent (BCR) prostate cancer following prior radical prostatectomy. The primary objective of the study is to compare the sensitivity of 68 Ga-PSMA-11 PET/CT with conventional imaging modalities, including CT and bone scintigraphy, for the detection of metastatic lesions. Secondary objectives include evaluating diagnostic performance for local and distant lesions, safety and tolerability, and the impact of imaging findings on clinical management decisions.
Telix is preparing an NDA for submission in Japan, with clinical data from the Phase 3 local study intended to support the application. In parallel, Telix’s application for Conditional Approval is under review by the Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). If granted, Conditional Approval will enable an expedited NDA review process while the final study clinical dataset is prepared.
Completion of enrollment represents a significant milestone for the study and advances Telix’s registration strategy for Illuccix® in Japan, one of the world’s largest nuclear medicine markets. The study complements Telix’s early access and broader prostate cancer portfolio activities in Japan, including named patient use for TLX591-Px [4] and patient enrollment in the Phase 3 ProstACT Global study of TLX591-Tx (lutetium ( 177 Lu) rosopatamab tetraxetan) [5] in advanced prostate cancer.
David N. Cade, MD, Group Chief Medical Officer, Telix, said, “Completion of patient enrollment into this pivotal Phase 3 study was rapid and represents a significant step towards the registration of Illuccix in Japan. We are grateful to the patients, investigators and dedicated study teams across the 11 sites for their commitment to this important study. Together, our goal is to expand access for Japanese men to the benefits of PSMA-PET imaging and thus improve outcomes for men in Japan living with prostate cancer.”
[1] TLX591-Px (Illuccix®), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally, excluding in Japan where use is investigational only.
[2] Japan Registry of Clinical Trials identifier: JRCT2031250473.
[3] Positron emission tomography/computed tomography.
[4] Since January 2024, Telix has supported the Japanese version of compassionate use of TLX591-Px in Japan through site-requested supply, consistent with local regulation.
[5] ClinicalTrials.gov ID: NCT06520345 .
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