Exogenous Testosterone Plus Dutasteride for the Treatment of Castrate Metastatic Prostate Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

November 30, 2012

Study Completion Date

November 30, 2012

Conditions
Prostate CancerCastration-resistant, Metastatic
Interventions
OTHER

testosterone (AndroGel®) with the 5α-reductase inhibitor dutasteride

"Patients will be treated with dutasteride 3.5 mg once daily (oral administration). To avoid rapid conversion of testosterone to DHT in case 5α-reductase is not adequately inhibited during the first few days of concurrent treatment with dutasteride and testosterone, daily dutasteride treatment will be initiated 7 days prior to testosterone initiation.~Patients will receive AndroGel® at the dose of 15 g (3 times the standard replacement dose for hypogonadism) once daily (topical administration), starting on Day 8 and continuing for 12 weeks (or until disease progression or withdrawal from the study)."

Trial Locations (1)

10065

Memorial Sloan-Kettering Cancer Center, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

University of Washington

OTHER

lead

Memorial Sloan Kettering Cancer Center

OTHER