Kamakura, Japan – January 30, 2026 – The first patient has been enrolled in a crucial Phase III study evaluating a novel imaging agent for prostate cancer, potentially expanding access to more accurate diagnostics in Japan. Telix Pharmaceuticals initiated the trial of TLX591-Px (Illuccix, Kit for the preparation of 68Ga-PSMA-11) at Shonan Kamakura General Hospital, marking a important step toward improved prostate cancer management.
New Imaging Trial offers Hope for More Precise Prostate cancer Detection
The study will assess the effectiveness of 68Ga-PSMA-11 PET/CT scans compared to standard imaging techniques in identifying the spread of prostate cancer.
- The open-label, multi-center trial will enroll up to 105 Japanese men.
- Researchers will compare the sensitivity of 68Ga-PSMA-11 PET/CT to CT scans and bone scintigraphy.
- the study aims to support a future marketing authorization submission for TLX591-Px in Japan.
- The trial will evaluate both distant and local lesion detection, and also the imaging agent’s safety and tolerability.
This new study focuses on biochemically recurrent prostate cancer patients who have undergone prior radical prostatectomy. The core question researchers are tackling is: how does 68Ga-PSMA-11 PET/CT stack up against traditional imaging when it comes to pinpointing metastatic lesions?
Evaluating Accuracy and Impact on Treatment
The Illuccix Japan study is designed to be prospective, meaning data will be collected as the trial progresses. Eleven sites across Japan will participate in enrolling the 105 men. Beyond simply detecting cancer spread, the trial will also assess how this advanced imaging approach might influence clinical decisions regarding patient care.
“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,” explained Dr. David Cade, chief medical officer at Telix Group. “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.”
Dr. Cade added that this milestone, coupled with the company’s existing compassionate use program, represents a significant move toward improving access to gallium-based PSMA-PET imaging and ultimately, improving outcomes for men in Japan battling prostate cancer.
TLX591-Px (Illuccix) has already received regulatory approvals in numerous global markets, but remains investigational within Japan. In June 2025, Telix also introduced AlFluor, a PET radiochemistry solution based on F-aluminium fluoride (AlF).
