A randomised, parallel arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of prostate size reduction in prostate cancer patients of i...

Update Il y a 5 ans
Reference: EUCTR2008-005232-33

A randomised, parallel arm, open-label trial comparing degarelix with goserelin plus anti-androgen flare protection (bicalutamide), in terms of prostate size reduction in prostate cancer patients of intermediate-to-high risk, who require neoadjuvant hormone therapy prior to radiotherapy (curative intent)

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Extract

To demonstrate that the mean percentage reduction in prostate volume with degarelix is non-inferior to goserelin plus bicalutamide, based on a trans-rectal ultrasound scan (TRUS) at 12 weeks (Visit 5=End of Trial [EoT] Visit) compared to baseline (Visit 2 - Randomisation)


Inclusion criteria

  • Prostate cancer