Phase III trial of intermittent degarelix therapy to be started


Ferring Pharmaceuticals has announced the company’s intent to initiate a randomized, controlled, multi-center trial of degarelix used as intermittent androgen deprivation therapy (IADT) in patients with advanced prostate cancer who have rising serum PSA levels after previous curative therapies.

According to the company’s media release, “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.”

According to Dr. E. David Crawford, one of the trial investigators,“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.”

No information was available as to when this trial would be started or whether it would be available for patient recruitment exclusively within the USA. A different trial is already enrolling patients in Europe in an uncontrolled, multi-center, pilot study of intermittent degarelix therapy.

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