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A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- leuprolide acetate) in Combination with TAXOTERE® (docetaxel) Administered Every Three W...

Update Il y a 4 ans
Reference: EUCTR2004-002203-32

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 in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

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Extract

The primary objective of the study is to compare progression-free survival (PSA progression after systemic treatment, radiologically or histologically documented progression after systemic treatment or death from any cause, whichever occurs first), using a 2x2 factorial design among treatment groups as follows: • Immediate treatment following prostatectomy [Treatment Arms: I(CHT), I(HT)] versus deferred treatment at the time of relapse [Treatment Arms: D(CHT), D(HT)] • TAXOTERE® q3w plus ELIGARD® (leuprolide acetate) [Treatment Arms: I(CHT), D(CHT)] versus ELIGARD® alone [Treatment Arms: I(HT), D(HT)]

Inclusion criteria

  • Prostate Cancer at High Risk of Relapse After Radical Prostatectomy

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