Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

June 30, 2010

Study Completion Date

January 31, 2014

Conditions
CancerProstate Neoplasms
Interventions
DRUG

goserelin with dutasteride

Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week.

DRUG

goserelin with bicalutamide and dutasteride

Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd.

DRUG

goserelin with bicalutamide and dutasteride and ketoconazole

Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg).

Trial Locations (2)

98108-1532

Veterans' Administration Puget Sound Health Care System (VAPSHCS), Seattle

98195-6158

University of Washington, Seattle

Sponsors
All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

University of Washington

OTHER