Eckert & Ziegler announced that the Clinical Trial Notification (CTN) of a joint clinical study with Novartis Pharma K.K. (Japan) was accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for 68Ga-PSMA-11, an investigational radioligand imaging agent and 177Lu-PSMA-617, an investigational radioligand therapy in metastatic prostate cancer. Eckert & Ziegler Radiopharma GmbH is manufacturer of the pharmaceutical 68Ge/68Ga generator GalliaPharm(R), which is used to produce the radiopharmaceutical 68Ga-PSMA-11 for 68Ga PET/CT diagnostics. This diagnostic procedure may be used to detect the presence of prostate-specific membrane antigen (PSMA) on prostate cancer cells, enabling localization of tumors. PSMA is found in high concentration on the surface of prostate cancer cells, making it a potentially effective target for imaging. Investigational imaging agent 68Ga-PSMA-11 has been shown to bind selectively to the PSMA receptor, allowing localization of prostate carcinoma. The same principle may also be used for therapy. In this case, PSMA-617 is attached to the therapeutic radioisotope 177Lu. Prostate cancer is the most common cancer among males in Japan, with over 106,000 cases in 2020, a significantly higher incidence than stomach cancer (95,000 new cases) or lung cancer (94,500 new cases) (IARC Global Cancer Observatory, 2020).