Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

PHASE2UnknownINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

March 28, 2015

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2024

Conditions
Adenocarcinoma of the Prostate
Interventions
DRUG

Enzalutamide

Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)

RADIATION

SRT

Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx

Trial Locations (9)

20016

Sibley Memorial Hospital, Washington D.C.

20814

Suburban Hospital, Bethesda

21287

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

47904

Indiana University, Lafayette

48109

University of Michigan Health System, Ann Arbor

48201

Karmanos Cancer Center, Detroit

60637

University of Chicago Medical Center, Chicago

84112

University of Utah - Huntsman Cancer Center, Salt Lake City

97239

Oregon Health Sciences University, Portland

Sponsors
All Listed Sponsors
collaborator

Astellas Pharma Inc

INDUSTRY

collaborator

Medivation, Inc.

INDUSTRY

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER