Comparison of degarelix and goserelin in patients with prostate cancer

• Research type

  Research Study

• Full title

  An Open-label, Multi-Centre, Extension Trial, Evaluating the Long-Term Progression-Free Survival of Degarelix or Goserelin Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

• IRAS ID

  65833

• Contact name

  Robert Huddart

• Sponsor organisation

  Ferring Pharmaceuticals A/S

• Eudract number

  2010-021434-55

• ISRCTN Number

  n/a

• Research summary

  Prostate cancer is the most frequent cancer diagnosed in men. Treatment decisions are often based on the disease at presentation. In advanced prostate cancer, treatment options are more or less palliative. Therapy to reduce testosterone has become one of the most commonly used procedures in recent decades, aimed at slowing disease progression and alleviating symptoms.Degarelix is a man-made protein derivative of a naturally occurring hormone called gonadotrophin-releasing hormone (GnRH). Degarelix competes with natural GnRH for binding to its receptors in the pituitary gland. The binding of degarelix blocks the release of FSH and LH, which in turn causes a rapid and sustained decrease in the production and release of testosterone by the testes. The sponsor of this study, Ferring Pharmaceuticals A/S, has developed a one-month dosing regime with degarelix and is now developing a three-month regime.This current study is an extension to the CS35 study. The purpose of this study is to compare the long-term effects of degarelix with goserelin (standard treatment for prostate cancer). Patients in the CS35 study were randomly assigned to receive degarelix or goserelin in a 2:1 ratio. Degarelix is given as two injections and goserelin is given as one injection every 3 months at the clinic. Patients will continue on the same treatment they received in the CS35 study.Patients will attend the clinic every 3 months for an additional period of 2 years. During these study visits, procedures will include vital signs, ECG, blood and urine samples. Participants will be asked about their general health and current medications at each visit. At the end of the study, participants will be offered appropriate treatment for their prostate cancer.Approximately 450 patients will participate in this study in Europe and the Americas with up to 7 patients from 3 hospitals in the UK.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  10/H0605/75

• Date of REC Opinion

  17 Dec 2010

• REC opinion

  Further Information Favourable Opinion