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| |  Degarelix Reduces PSA and Testosterone Levels Faster Than Leuprolide in Prostate Cancer Patients on Androgen Deprivation: Presented at AUA By Ric Susman ORLANDO, Fla -- May 23, 2008 -- The investigative gonadotrophin-releasing hormone agonist degarelix significantly reduced levels of prostate specific antigen (PSA) and testosterone better than leuprolide in patients with hormone-dependent prostate cancer, according to research presented here at the American Urological Association (AUA) Annual Meeting. Laurence Klotz, MD, Professor of Surgery, University of Toronto, and Chief, Division of Urology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada, reported the results in a late-breaking clinical trial presentation on May 20. In the trial, all patients were treated with degarelix 240 mg at baseline and then were randomised to receive subcutaneous degarelix 160 mg (n = 202) or 80 mg (n = 207) once monthly for 1 year. A third group of 201 men were randomised to monthly leuprolide 7.5 mg depot injections for 1 year. The goal of treatment was a testosterone level <=0.05 ng/mL. Patients' average age was 72 years; about 90% had a Gleason score of 5 to 10. Median PSA at baseline for the degarelix patients was 19.8 ng/mL and for leuprolide patients it was 17.4 ng/mL. Response rates were 98.3% in the degarelix 160 mg treatment arm, 97.2% with degarelix 80 mg, and 96.4% with leuprolide. "Degarelix showed a fast onset of action," said Dr. Klotz. By day 3, 97% of patients taking degarelix 160 mg/day and 96% of patients taking degarelix 80 mg/day had achieved testosterone levels <=0.05 ng/mL. None of the patients on leuprolide reached this goal by day 3 (P < .001). "Both doses of degarelix were at least as effective as leuprolide in terms of response to treatment," he said. As of day 28, patients on both drugs were able to maintain reduced testosterone levels through the 1-year course of the study. Reductions in PSA levels also occurred significantly faster with degarelix, Dr. Klotz said. At day 14, degarelix patients achieved a 64% to 65% reduction in PSA levels compared with an 18% reduction with leuprolide (P < .001). At day 28, patients on degarelix achieved an 85% reduction in PSA level compared with a 70% reduction with leuprolide (P < .001). At day 56, reductions in PSA levels were similar with the 2 agents, achieving better than a 90% reduction in PSA levels. "Degarelix was well tolerated," Dr. Klotz said, "with no serious adverse events related to treatment and no systemic allergic reactions observed."
[Presentation title: Degarelix in a 12-Month, Randomized, Open-Label, Parallel-Group Phase III Study in Prostate Cancer Patients.]
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