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A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER Studio mu...

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Reference: EUCTR2013-003820-36

A MULTINATIONAL, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE III EFFICACY AND SAFETY STUDY OF ODM-201 IN MEN WITH HIGH-RISK NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER Studio multinazionale, randomizzato, in doppio cieco, controllato con placebo, di Fase III, per valutare l’efficacia e la sicurezza di ODM-201 in pazienti di sesso maschile con cancro della prostata resistente alla castrazione non metastatico ad alto rischio

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Extract

The primary objective of this study is to demonstrate the superiority of ODM-201 vs. placebo in metastasis free survival (MFS) in patients with high-risk nmCRPC

Inclusion criteria

  • High-risk, non-metastatic castration-resistant prostate cancer (MedDRA: hormonerefractory prostate cancer),cancro della prostata resistente alla castrazione non metastatico ad alto rischio (MedDRA: cancro alla prostata ormone refrattario)

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