Date: 2017-06-09
Type of information: update on patient enrollment
phase: 3
Announcement: update
Company: Medivation (USA - CA), now Pfizer (USA - NY) Astellas (Japan)
Product: Xtandi® (enzalutamide)
Action mechanism: androgen receptor inhibitor. Xtandi® (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. It has been shown to competitively inhibit androgen binding to androgen receptors and inhibit androgen receptor nuclear translocation and interaction with DNA. A major metabolite, N-desmethyl enzalutamide, exhibited similar in vitro activity to Xtandi®. Xtandi® decreased proliferation and induced cell death of prostate cancer cells in vitro, and decreased tumor volume in a mouse prostate cancer xenograft model.
Disease: non metastatic castration-resistant prostate cancer
Therapeutic area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Republic of Korea, Malaysia, The Netherlands, New Zealand, Poland, Russian Federation, Serbia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, UK, USA
Trial details: The PROSPER study is a multi-national, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Xtandi® (enzalutamide) in patients with non-metastatic (M0) Castration-Resistant Prostate Cancer (CRPC). (NCT02003924)
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