Ferring Pharmaceuticals, a biopharmaceutical company, has launched a Phase IIIb clinical trial of degarelix for injection, a new injectable gonadotropin-releasing hormone receptor antagonist approved by the FDA for the treatment of hormone sensitive advanced prostate cancer.
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 prostate specific antigen (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.
David Crawford, trial investigator, said: 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. 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.
Ferring is a research driven, speciality biopharmaceutical group. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynaecology, and fertility.