3 monthly Degarelix versus Goserelin in prostate cancer patients

• Research type

  Research Study

• Full title

  An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen with Goserelin Acetate in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

• IRAS ID

  24689

• Contact name

  Robert Huddart

• Eudract number

  2008-005276-27

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  In advanced prostate cancer, therapy to reduce testosterone has become one of the most commonly used procedures in recent decades. The aim is to slow disease progression and alleviate symptoms. The sponsor of this study, Ferring Pharmaceuticals A/S, has developed a one-month dosing regime with a drug called degarelix and is now developing a three-month regime. The purpose of this study is to compare the effects of degarelix with goserelin which is one of the most commonly used drugs in advanced prostate cancer. Eligible participants will be assigned randomly to receive either degarelix or goserlein. There is a 2 in 3 chance of being assigned degarelix and a 1 in 3 chance of being assigned goserelin. Participants in the degarelix group will receive the first dose as 2 injections and the next four doses will be given as 2 injections at three-monthly intervals starting one month after the first dose is given. Participants in the goserelin group will receive the first dose as 1 injection and the next four doses will be given as 1 injection at three-monthly intervals starting one month after the first dose is given. Participants will be required to stay at the hospital clinic for observation for an hour after the injection(s). Although study injections are given three-monthly, participants will attend the clinic at least monthly for 13 months. During these visits, assessments will be performed including vital signs, examination of the heart using an electrocardiogram, blood and urine samples. Participants will be asked about their general health and current medications at each visit and will be asked to complete questionnaires about their quality of life at three-monthly intervals. At the end of the study, participants will be offered appropriate treatment for their prostate cancer. Approximately 825 patients will be enrolled in Europe and the Americas.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/86

• Date of REC Opinion

  20 Aug 2009

• REC opinion

  Further Information Favourable Opinion