August 30, 2024
Keio University Hospital
Keio University School of Medicine
Dr. Yoshio Nakamura, Senior Assistant Professor, and Dr. Ken Funakoshi, Associate Professor, from the Department of Dermatology, Keio University School of Medicine, and their colleagues will launch a new investigator-initiated clinical trial of endocrine therapy for patients with advanced extramammary Paget's disease starting in August 2024. This multicenter, phase II study will be conducted at seven sites in Japan: Niigata Cancer Center Hospital, the National Cancer Center Hospital, Shizuoka Cancer Center, Nagoya City University Hospital, Hyogo Cancer Center, the National Kyushu Cancer Center, and Keio University Hospital.
Extramammary Paget's disease is an adenocarcinoma that occurs on the skin, such as in the genital area. There is no established standard of care for cases where it has metastasized to organs like the lungs, and the development of new treatments is needed. Based on basic research conducted by this research group, which showed that the proliferation of cancer cells in extramammary Paget's disease was suppressed by darolutamide, an androgen receptor signaling inhibitor, this clinical trial was planned to confirm the efficacy and safety of anti-androgen therapy. This is the world's first clinical trial of anti-androgen therapy (endocrine therapy) for patients with extramammary Paget's disease.
This investigator-initiated clinical trial is being conducted as part of the "Clinical Research and Clinical Trial Promotion Program" of the Japan Agency for Medical Research and Development (AMED).
For the full press release, please see below.