Ferring Pharmaceuticals has 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 U.S. 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, IL.
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. The trial evaluates whether IADT minimizes the negative effects of ADT and maximizes quality of life, while maintaining tumor response as measured by PSA suppression.
"Intermittent androgen deprivation therapy is a commonly employed treatment for men with biochemical failure, however it needs to be evaluated in a randomized clinical trial," says Dr. E. David Crawford, Head Urologic Oncology, University of Colorado, Denver and a trial investigator. "There is potential value in combining the rapid, sustained suppression of testosterone that degarelix offers in this treatment. IADT appears to improve patient quality of life and that will also be evaluated."
Physicians interested in serving as trial investigators should call 1-973-796-1600 to speak with Ferring Pharmaceuticals' Medical Information office.
Degarelix Phase III Trials
Phase III pivotal studies showed that degarelix is as effective as leuprolide (Lupron Depot(R))(*)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) At Day 3 of treatment, the degarelix group achieved a 90 percent decrease in median testosterone levels compared with the leuprolide group, which experienced a 65 percent increase in median testosterone levels, a statistically significant result. Degarelix was as effective as leuprolide in suppressing testosterone levels from Day 28 to the end of the study (Day 364), with 97.2 percent of the degarelix patients maintaining medical castrate levels compared with 96.4 percent for leuprolide.
In addition, prostate-specific antigen (PSA) levels were lowered by 64 percent two weeks after administration of degarelix, 85 percent after one month, 95 percent after three months, and remained suppressed throughout the one year of treatment.(1)(2) These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.
About Degarelix