Phase IIIB Trial of Intermittent Degarelix Therapy Launched

Ferring Pharmaceuticals announced the launch of a phase IIIB clinical trial of degarelix for injection, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist approved by the US Food and Drug Administration (FDA) for the treatment of hormone-sensitive advanced prostate cancer. The announcement was made at the 2009 American Urological Association Annual Meeting in Chicago.

Building on a pivotal phase III study (see article beginning on page 626), the phase IIIB trial will investigate the use of degarelix for intermittent androgen deprivation therapy (IADT) in patients with advanced prostate cancer who have rising serum PSA levels after previous curative therapies. The study will compare IADT to continuous androgen deprivation therapy (ADT) for 14 months with either leuprolide or degarelix, evaluating whether IADT minimizes the negative effects of ADT and maximizes quality of life, while maintaining tumor response as measured by PSA suppression.