Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

PHASE3CompletedINTERVENTIONAL
Enrollment

228

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2010

Conditions
Prostatic Neoplasms
Interventions
DRUG

Docetaxel (TAXOTERE®) Chemotherapy

"75 mg/m\^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization.~Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy."

DRUG

Leuprolide acetate ( ELIGARD®) Hormonal Therapy

22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 8 days after randomization.

DRUG

Docetaxel (TAXOTERE®) Chemotherapy

"75 mg/m\^2 docetaxel administered IV over 1 hour on Day 1 q3w for 6 cycles. The first cycle was to be administered within 30 days after progression was confirmed.~Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy."

DRUG

Leuprolide acetate ( ELIGARD®) Hormonal Therapy

22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed (on Day 1 of docetaxel administration).

DRUG

Leuprolide acetate ( ELIGARD®) Hormonal Therapy

22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 30 days after progression is confirmed.

Trial Locations (17)

08807

Sanofi-Aventis Administrative Office, Bridgewater

Unknown

Sanofi-Aventis Administrative Office, Macquarie Park

Sanofi-Aventis Administrative Office, Vienna

Sanofi-Aventis Administrative Office, São Paulo

Sanofi-Aventis Administrative Office, Québec

Sanofi-Aventis Administrative Office, Paris

Sanofi-Aventis Administrative Office, Frankfurt

Sanofi-Aventis Administrative Office, Mumbai

Sanofi-Aventis Administrative Office, Netanya

Sanofi-Aventis Administrative Office, Milan

Sanofi-Aventis Administrative Office, Col. Coyoacan

Sanofi-Aventis Administrative Office, PE Gouda

Sanofi-Aventis Administrative Office, Warsaw

Sanofi-Aventis Administrative Office, Moscow

Sanofi-Aventis Administrative Office, Gauteng

Sanofi-Aventis Administrative Office, Istanbul

Sanofi-Aventis Administrative Office, Guildford Surrey

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY