Clinical trial

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

NCT00283062 · Sanofi, Industry · Completed

Key facts

NCT number NCT00283062
Title Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy
Official title A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- Leuprolide Acetate) in Combination With TAXOTERE® (Docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options…
Lead sponsor Sanofi, Industry
Status Completed
Phase Phase 3
Study type Interventional
Conditions Prostatic Neoplasms
Intervention type Drug
Interventions Docetaxel (TAXOTERE®) Chemotherapy, Leuprolide acetate ( ELIGARD®) Hormonal Therapy
Enrollment 228
Start date Dec 1, 2005
Primary completion Dec 1, 2010
Completion Dec 1, 2010
First posted Jan 27, 2006
Last update posted Jan 26, 2012
Countries Australia, Austria, Brazil, Canada, France, Germany, India, Israel, Italy, Mexico, Netherlands, Poland and 5 more

At a glance

  • 10–99 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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