Date: 2013-12-03
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Medivation (USA - CA) Astellas (Japan
Product: Xtandi® (enzalutamide)
Action
mechanism: 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 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 phase 3 randomized, double-blind, placebo-controlled, multi-national trial. The tria plans to enroll approximately 1,500 patients with non-metastatic castration-resistant prostate cancer at sites in the United States, Canada, Europe, South America and the Asia Pacific region. PROSPER will enroll a high-risk subgroup of patients with prostate cancer who are progressing despite androgen deprivation therapy, but who are asymptomatic with no prior or present evidence of metastatic disease. The primary endpoint of the trial is metastasis-free survival. The trial will evaluate enzalutamide at a dose of 160 mg to be taken orally once daily versus placebo, plus androgen deprivation therapy. (NCT02003924)
Latest
news: * On December 3, 2013, Medivation and Astellas Pharma announced enrollment of the first patient in a global Phase 3 clinical trial, known as PROSPER, which will evaluate the safety and efficacy of enzalutamide in patients with non-metastatic (often referred to as M0) castration-resistant prostate cancer (CRPC). Currently no prescription medicine is specifically approved for the treatment of patients with non-metastatic CRPC in the United States.
