Enzalutamide/Leuprolide +/- Abiraterone/Pred in Prostate

PHASE2CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

January 31, 2018

Study Completion Date

December 31, 2021

Conditions
Prostate AdenocarcinomaProstate CancerHigh Risk Prostate Cancer
Interventions
DRUG

Enzalutamide

160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Can be taken with or without food.

DRUG

Abiraterone Acetate

1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum. No food should be consumed for at least two hours before the dose and for at least one hour after the dose.

DRUG

Prednisone

5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.Take with food, preferred to be taken in the morning .

DRUG

Leuprolide Acetate

Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.

Trial Locations (4)

21231

Johns Hopkins University, Baltimore

98109

University of Washington, Seattle

02115

Beth Israel Deaconess Medical Center, Boston

Dana-Farber Cancer Institute, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medivation, Inc.

INDUSTRY

lead

Dana-Farber Cancer Institute

OTHER