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Degarelix (FIRMAGON(R)) vs Leuprolide (Lupron Depot(R)) in Patients With Advanced Prostate Cancer: Further Analysis From a Phase III Pivotal Trial
Date:12/4/2009

BETHESDA, Md., Dec. 4 /PRNewswire/ -- Drs. Neal Shore and E. David Crawford presented results for prostate-specific antigen (PSA) recurrence from the additional analysis of secondary end points of biochemical recurrence rate in a Phase III pivotal study of FIRMAGON® (monthly degarelix for injection) or monthly leuprolide in prostate cancer patients during the first year of treatment. Prostate cancer patients who received FIRMAGON 240/80 mg/month had a recurrence rate of 7.7% during the first year of treatment compared with 12.9% of patients treated with leuprolide 7.5 mg/month (p=0.05). Patients being treated with FIRMAGON also had longer time to recurrence compared with those on leuprolide (p=0.04).

Results of the PSA analysis were presented in a poster at the 10th Annual Meeting of the Society of Urologic Oncology, held in conjunction with the World Urological Oncology Federation, on December 3 in Bethesda, MD.

About the Study

In the Phase III multicenter, randomized, open-label trial comparing degarelix with leuprolide, prostate cancer patients (n=610) were randomized to a starting dose of degarelix 240 mg for one month, followed by monthly maintenance doses of 80 mg (n=207) or 160 mg (n=202), or leuprolide 7.5 mg/month (n=201). Results showed that degarelix is as effective as leuprolide in reducing and sustaining castrate levels of testosterone.(1),(2) Suppression of testosterone to castrate levels occurred significantly faster in patients receiving degarelix than in those receiving leuprolide.(1),(2) The study also showed that degarelix achieves faster suppression of luteinizing hormone and follicle-stimulating hormone.(1),(2)

PSA recurrence was defined as two consecutive increases in PSA of 50% compared with nadir and greater than or equal to 5 ng/mL on two consecutive measurements at least two weeks apart. PSA progression-free survival was analyzed using the Kaplan-Meier method and
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SOURCE Ferring Pharmaceuticals Inc.
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