Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 1, 2015

Primary Completion Date

March 31, 2020

Study Completion Date

March 31, 2021

Conditions
Prostate Cancer
Interventions
DRUG

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.

Trial Locations (4)

761-0793

Kagawa University Faculty of Medicine, Kita-gun

889-1692

University of Miyazaki Faculty of Medicine, Miyazaki

152-8902

Tokyo Medical Center, Meguro-ku

105-8461

The Jikei university school of medicin, Minato-ku

All Listed Sponsors
collaborator

Kagawa University

OTHER

lead

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

OTHER

NCT02588001 - Japanese Research for Patients With Non-metastatic Castration Resistant Prostate Cancer - Enzalutamide | Biotech Hunter | Biotech Hunter