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To assess & compare the impact on disease control & patient & practitioner experience between the 6-monthly study drug & available 3-monthly injections. Comparison of the proportions of patients medic...

Update Il y a 4 ans
Reference: EUCTR2011-004213-16

To assess & compare the impact on disease control & patient & practitioner experience between the 6-monthly study drug & available 3-monthly injections. Comparison of the proportions of patients medically castrated & their PSA levels at 6 and 12 months between the 6-monthly study drug & 3-monthly injections. Review of patient satisfaction & preference for the 6-monthly study drug compared to 3-monthly injections & explore the effects of the 6-monthly study drug on the patients’ Quality of Life

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Extract

Primary Study Objective The primary objective of this study is to demonstrate non-inferiority of Decapeptyl SR 22.5mg to a standard 3-monthly LHRH agonist in maintaining biochemical castration (testosterone levels ≤0.5ng/mL) after 6 months’ treatment.

Inclusion criteria

  • locally advanced and metastatic prostrate cancer

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