A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

PHASE3TerminatedINTERVENTIONAL
Enrollment

413

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

September 30, 2012

Study Completion Date

September 30, 2012

Conditions
Prostatic Neoplasms
Interventions
DRUG

Docetaxel

75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.

DRUG

Leuprolide

22.5 mg injection subcutaneously every 12 weeks up to 18 months.

DRUG

Bicalutamide

50 mg tablet orally once daily for first 4 weeks of treatment.

Trial Locations (9)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Diegem

Sanofi-Aventis Administrative Office, Laval

Sanofi-Aventis Administrative Office, Prague

Sanofi-Aventis Administrative Office, Frankfurt

Sanofi-Aventis Administrative Office, Vilnius

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Bratislava

Sanofi-Aventis Administrative Office, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY