Degarelix as neoadjuvant hormone therapy in patients with prostate cancer: Results from a phase IIIb randomized, comparative trial versus goserelin plus bicalutamide.

e15199^ Background: The current approach in patients with high-risk localised or locally advanced PCa is ADT prior to radiotherapy, which improves disease-specific and overall survival vs radiotherapy alone. Whether degarelix, a GnRH antagonist performs comparably with the use of GnRH agonist under flare protection in neoadjuvant settings has not yet been investigated. Methods: Patients with intermediate to high risk PCa were randomised (3:1) to receive either degarelix or goserelin plus bicalutamide (G+B) for 12 wks. The primary endpoint was the percentage reduction from baseline in prostate volume at wk 12 as measured by TRUS. The non-inferiority margin was -10%. Other endpoints included changes in the IPSS, testosterone and PSA. Results: 177 in the degarelix and 62 patients in the G+B arm have completed the trial. 62% and 38% of the patients had localised and locally advanced PCa, respectively. The primary endpoint was successfully met establishing noninferiority between the two treatments in terms of ...