Degarelix Versus Goserelin Plus Bicalutamide in the Short‐Term Relief of Lower Urinary Tract Symptoms in Prostate Cancer Patients: Results of a Pooled Analysis

Objective In patients with prostate cancer ( PCa ), prostate enlargement may give rise to lower urinary tract symptoms ( LUTS ); many patients suffer from moderate‐to‐severe symptoms. We compare the efficacy of degarelix and goserelin plus bicalutamide in improving LUTS in PCa patients. Methods Data were pooled from three P hase 3, randomized clinical trials of once‐monthly treatment for 12 weeks with degarelix (240/80 mg; n =  289) or goserelin (3.6 mg) plus bicalutamide (50 mg; n =  174) for initial flare protection. LUTS at weeks 4, 8, and 12 were compared to baseline. Clinically relevant LUTS relief was a ≥3‐point International Prostate Symptom Score ( IPSS ) decrease. Adverse events were assessed throughout the trials. Results Patients receiving degarelix had significantly greater decreases in IPSS vs. goserelin at week 12 (adjusted difference: −1.24; 95% CI −2.33 to −0.14, P  = 0.03). Clinically relevant LUTS relief with degarelix was especially pronounced in patients with moderate‐to‐severe LUTS (baseline IPSS ≥13) (odds ratio; OR 2.31; 95% CI 1.19–4.47, P  = 0.01) and advanced PCa ( OR 2.36; 95% CI 1.10–5.04, P  = 0.03). A twofold higher OR for early (week 4) LUTS relief was seen with degarelix vs. goserelin ( OR 2.03; 95% CI 1.14–3.60, P  = 0.02). No difference in total prostate volume or urinary tract infection‐related adverse events (2%) was seen between treatment groups. Conclusion An early, significant and clinically more pronounced improvement of LUTS , especially in patients with moderate‐to‐severe LUTS or advanced PCa , was seen with degarelix vs. goserelin plus bicalutamide.