Phase III International Clinical Trial of 18F-PSMA-1007 has been initiated in Japan
April 25, 2025
Sumitomo Heavy Industries, Ltd. (Head Office: Shinagawa-ku, Tokyo; President and CEO: Shinji Shimomura; hereinafter the “Company”), the National Research and Development Agency, the National Cancer Center Hospital, The University of Osaka Hospital (Head Office: Suita, Osaka: Director: Norio Nonomura) have already initiated Phase-III multi-center, prospective, international clinical trial of 18F-PSMA-1007 PET/CT examination for patients with an initial diagnosis of prostate cancer with high-risk or very-high-risk. (hereinafter “this clinical trial”). Sumitomo Heavy Industries, Ltd. hereby announces that the first patient of this clinical trial has been enrolled and the 18F-PSMA-1007 PET/CT conducted.
This clinical trial will evaluate the region-based, patient-specific sensitivity and specificity of PET/CT scans for pelvic lymph node metastasis (N1) in patients with newly diagnosed high-risk and very-high-risk prostate cancer using 18F-PSMA-1007 *1, a PET probe for prostate cancer. ABX advanced biochemical compounds GmbH*2 in this clinical trial. Prostate cancer is the most common cancer among Japanese men. *3 We expect that the accurate diagnosis of pelvic lymph node metastasis by 18F-PSMA-1007 PET/CT scan could be beneficial for optimal treatment of patients. We will continue our development for the better convenience and expansion in several indications to increase the availability of PET/CT scans in Japan.
| Indication | [18F]PSMA-1007 as PET-CT imaging agent for the detection of metastases of prostate cancer in patients with newly diagnosed, biopsy-proven prostate cancer |
| Study objective (Primary) |
To assess, in an independent assessment by 3 readers blinded to the clinical data, the sensitivity and specificity of [18F]-PSMA-1007 positron-emission, computer-aided tomography (PET-CT) in detecting pelvic nodal metastases (N1) in newly diagnosed high-risk and very-high-risk prostate cancer (region-based patient-level analysis, at least one hemi-pelvis is correctly diagnosed), using histology as the standard of reference. |
| Study centers | National Cancer Center Central Hospital (PI: Kimiteru Ito)
The University of Osaka Hospital (PI: Tadashi Watabe) |
| Contract period | Until 30 June, 2026 |
| Detailed information | https://jrct.mhlw.go.jp/latest-detail/jRCT2032240674 |
(*1) A PET probe that accumulates at prostate-specific membrane antigen (PSMA), the exclusive rights of the development, production, and sales of which are held by ABX advanced biochemical compounds GmbH, Germany. The domestic rights holder is Otsuka Pharmaceutical Co, Ltd. (https://www.otsuka.co.jp/en/)
(*2) ABX advanced biochemical compounds Biomedizinische Forschungsreagenzien GmbH
(https://abx.de/), part of Otsuka group
(*3) Cancer Statistics. Cancer Information Service, National Cancer Center Japan
(https://ganjoho.jp/reg_stat/statistics/stat/summary.html)