Date: 2015-06-17
Type of information: Recruitment of the first patient
phase:
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: castration-resistant prostate cancer (CRPC)
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: TRUMPET (Treatment Registry for Outcomes in CRPC Patients), is a prospective observational registry study designed to better understand the needs and treatment patterns for patients with castration-resistant prostate cancer (CRPC) in the United States. TRUMPET is assessing patient care patterns and does not evaluate any specific treatment or medication.
Latest
news: * On June 17, 2015, Medivation and Astellas announced that the first patients have been enrolled in TRUMPET (Treatment Registry for Outcomes in CRPC Patients), a prospective observational patient registry designed to better understand the unique needs and treatment patterns for patients with castration-resistant prostate cancer (CRPC). The registry will enroll and evaluate 2,000 patients diagnosed with CRPC from urology and oncology sites across the United States. The study will also collect data from the primary caregivers of patients, including spouses, family members and/or friends. TRUMPET will follow patients with CRPC and participating caregivers for up to six years to gather information about the management of the disease, including patterns of care, treatment decisions and settings, and physician referral patterns. The registry will also track information about patient health-related quality of life outcomes, work productivity and treatment satisfaction, as well as caregiver health-related quality of life outcomes associated with managing a patient with CRPC. TRUMPET is currently enrolling eligible patients and their caregivers; the study will be completed in 2020.
