60
Participants
Start Date
October 1, 2015
Primary Completion Date
March 31, 2020
Study Completion Date
March 31, 2021
Enzalutamide
All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment.
Kagawa University Faculty of Medicine, Kita-gun
University of Miyazaki Faculty of Medicine, Miyazaki
Tokyo Medical Center, Meguro-ku
The Jikei university school of medicin, Minato-ku
Kagawa University
OTHER
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER